Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04295122 |
| Other study ID # |
263262 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2020 |
| Est. completion date |
March 14, 2023 |
Study information
| Verified date |
February 2020 |
| Source |
Guy's and St Thomas' NHS Foundation Trust |
| Contact |
Lina Danieliute, MSc, PGCert |
| Phone |
02071884885 |
| Email |
lina.danieliute[@]gstt.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Laser endoscopic cyclophotocoagulation (ECP) has been in use for the treatment of glaucoma
for over 20 years and is usually used in conjunction with cataract surgery. In the US it is
one of the most commonly performed cataract 'plus' surgeries. The take-up of ECP laser has
been much lower in the UK and Europe. This is partly due to the lack of robust clinical
evidence from randomised controlled trials to justify its use in routine practice. More
recently the advent of minimally invasive glaucoma surgery techniques (MIGS) has increased
the options available for cataract 'plus' surgery. Without any randomised controlled trial
data for the use of ECP laser in this context the increasingly popular use of MIGS devices,
such as iStent (the current market leader) may further marginalise the use of ECP laser for
cataract 'plus' surgery in patients with Primary Open Angle Glaucoma (POAG) and visually
significant cataract.
To further evaluate the use of ECP laser for the treatment of glaucoma in patients with
glaucoma and cataract, investigators plan to conduct a randomised controlled trial comparing
cataract surgery alone versus cataract surgery plus ECP laser surgery. Investigators will
compare the efficacy of these interventions for the treatment of glaucoma based on clinical
outcomes and also undertake a cost-benefit analysis, taking into account the cost of surgery,
any reduction in clinical time allocation for procedures, the frequency of intra- and
post-operative complications, and any reduction in the need for topical glaucoma treatments
post-surgery, as well as the frequency with which further glaucoma filtering surgery is
needed for patients in each group.
Investigators anticipate that a total number of 160 patients (80 in each arm) will be
adequate to detect whether there is any difference in efficacy between cataract surgery + ECP
versus cataract surgery alone. Recruitment is expected to take around 9-12 months.
Participants will undergo treatment wash-out (28 days minimum) of any eye drops they use for
their glaucoma prior to data collection at baseline (before surgery) and prior to data
collection at one-year and at two-years post-surgery. Results will be reviewed during an
interim analysis at 6 months once 50 patients have reached that time point.
Description:
The study compares one off surgical interventions that are in routine clinical use and
therefore there are no major ethical issues. All participants will be eligible for cataract
surgery. Participants will be randomly allocated to one or other of the treatment arms.
Explicit written consent for randomisation will be obtained and recorded on the consent form.
The available evidence does not indicate that there are substantially greater risks of intra-
and post-operative complications associated with combined ECP plus cataract surgery compared
with cataract surgery alone.
Participants may be asked to attend an additional visit for the baseline pre-operative data
collection. The tests undertaken at this visit would therefore be additional non-routine
procedures. If the baseline data collection is undertaken at an additional, rather than a
routine visit, then travel expenses to will be paid for the extra non-routine visit.
At the some visits additional tests will be performed that would not normally be routinely
undertaken with glaucoma patients at those visits. All of the tests that will be done for the
study are routinely performed in ophthalmology out-patient clinics, but the non-routine tests
may not be routinely performed with glaucoma patients or may not be routinely performed at
all visits.
Participants will be asked to stop using their eye drops for glaucoma at least 28 days before
the pre-operative baseline measurements are taken and again at least 28 days before the 1
year and 2 years post-operative measurements are taken (if they continue to need eye drops
after surgery). This will not cause participants any harm and will not have a clinical impact
on their glaucoma or their vision. Including a treatment washout period is common practice in
glaucoma research. If it is not clinically safe for a patient to stop taking the eye drops
they use to treat their glaucoma or ocular hypertension for 4 weeks, or if they are not
willing to stop using their eye drops for 4 weeks, then they will be excluded from the study.
To minimise risk only patients with mild to moderate glaucoma will be included. Those with
advanced disease will be excluded. The treatment washout will not cause any delay to the
surgery as the usual waiting time for surgery is 1-2 months.
To be on the safe side some participants may be asked to come in two weeks after stopping
taking their eye drops so the investigators can do a safety check of the pressure in their
eyes. Most patients who take part in the study will not need this. If investigator do ask a
participant to come in for a safety check this will be an extra appointment that they would
not normally be asked to come to if the participant were not taking part in the study, so the
travel expenses will be paid. It will be a brief appointment (10-15 minutes) to check the
intraocular pressure by Goldmann applanation tonometry. This is the standard test for
intraocular pressure that is performed at all routine glaucoma clinic visits. Participants
may potentially need to come in for three IOP safety check visits if a washout is required
before the 1 year and 2 years follow-up visits because treatment by eye drops is continued
after surgery.
Participants will be asked to come to the all of the appointments that they would be asked to
attend if they were not taking part and will receive the same post-operative clinical care
that they would receive if not taking part.
Benefits
There are no benefits to participants. However, the study aims to help us to understand more
about how best to treat glaucoma and as relatives of people with glaucoma have a higher than
normal risk of developing glaucoma, the study could in the future be of benefit to
participants' relatives.
2. Trial design and statistics
2.1 Trial Design The study will be a single blinded prospective randomised two armed surgical
trial to compare the effectiveness and cost effectiveness of phacoemulsification combined
with ECP laser versus phacoemulsification alone for the treatment of early or moderate open
angle glaucoma (OAG) in patients with visually significant cataract eligible for
phacoemulsification (cataract surgery). Treatment allocation will be masked for participants.
As the study team includes the surgeons who perform the surgical procedures the investigators
will not be masked as to which treatment the patient receives.
Settings
This study will be conducted in the Ophthalmology Department at St Thomas' Hospital (Guy's
and St Thomas' NHS Foundation Trust). Other sites in the UK will be invited to participate if
the recruitment rate is below expectation.
Trail duration Patients will be recruited for 9-12 months up to a maximum of 160 patients
(with up to 80 allocated to each arm). Patients' participation will last for up to 2 years
and 6 months consisting of a maximum of 60 days from screening/enrolment to the commencement
of treatment washout, a maximum of 60 days treatment washout, a maximum of 60 days from the
baseline measurements to surgery, and then 2 years post-operative follow-up. The total study
duration with therefore be up to 3 years and 6 months (up to 12 months recruitment plus up to
2 years and 6 months for the last participant to complete the study).
2.3 Outcome Measures Primary outcome - change in post-washout IOP of at least 2.7 mmHg at 12
and 24 months from baseline. The IOP will be measured using Goldmann applanation tonometer at
each visit.
Secondary outcomes:
1. The % of patients with reduction of mean diurnal IOP of ≥ 20% from baseline at 24 months
following medication washout. (Note: throughout this protocol, the term "diurnal IOP" is
synonymous with "washed out diurnal IOP".)
2. Change in number of glaucoma medication used at 24 months from baseline.
3. Cost effectiveness. This will be assessed by collecting the flowing parameters:
1. Time needed for surgery.
2. Time for personnel (process mapping).
3. Cost of laser. Other Measures
4. Clinic visits (patient questionnaire).
5. GP visits (patient questionnaire).
6. Pharmacy visits (patient questionnaire).
7. Medications (patient questionnaire).
8. Further glaucoma surgery (patient questionnaire). If yes, which one? How many?
9. Complication related to the initial surgery (operation note and CRF review).
4. Intra- and Post - operative complication rates:
Safety outcomes include:
- Loss of > 2 lines of BCVA.
- Slit lamp and fundus examination findings.
- The incidence of complications and adverse events.
2.4 Trial statistics and analysis
Power Calculation and Sample Size Estimate
A sample size of 58 in each group will have 90% power to detect a difference in means of
2.7 (the difference between a Group 1 mean, µ₁, of 4.5 and a Group 2 mean, µ₂, of 1.8)
assuming that the Group 1 standard deviation, σ₁, is 5.13 and the Group 2 standard
deviation, σ₂, is 3.61 (ratio of Group 2 to Group 1 standard deviation is 0.704) using a
two group Satterthwaite t-test with a 0.05 two-sided significance level.
Allowing for up to 20% loss to follow-up, 80 patients in each arm will be required for
this study, with a total number of 160 patients.
Statistical Analysis Baseline characteristics of the groups will be summarised with
means and standard deviations for continuous data (normally distributed) or medians and
inter quartile ranges (non-normal) and numbers with percentages for categorical
variables. Outcomes will be reported in a similar fashion again by treatment group.
Treatment differences will be estimated with 95% confidence intervals analysed.
Investigators will analyse on an ITT basis. Missing data will be evaluated and
summarised by reason. Should data be missing investigators will report the reasons for
this and assess whether or not it appears related to treatment status. Where
participants are withdrawn or choose to withdraw prior to randomisation they will not be
included in the final analysis.
Cost Effectiveness Analysis (UK Model)
The cost effectiveness analysis will look at the current care pathway and outline how
ECP laser will affect the time taken to do a procedure by understanding the current
standard of care for a Glaucoma patient post operatively and costs associated at each
stage. Formulating a quantitative care pathway model will effectively assess how ECP
laser could allow for cost benefits within the NHS. The secondary focus of this RCT will
be look at current standards and compare how time and resources can be effectively
reduced by implementing ECP laser. A budget impact model can be created once the RCT
complete and data for cost benefit which will be used for payer groups. The cost benefit
will look at the following below:
- Time reductions - If using ECP as the new standard of care (instead of drainage
surgery), time reductions operatively will allow for more surgical procedures to be
performed in theatres, which will benefit NHS Trusts.
- Change in number of glaucoma therapeutic drugs - Cost savings can be naturally made
if the surgical procedure is sustainable over a period of 2 years.
Criteria for discontinuation/early withdrawal of participants from the study
Failure to meet eligibility criteria prior to randomisation
Enrolled patients may be withdrawn from the study during the pre-baseline treatment
washout, after the baseline data collection and after cataract surgery if they are
ineligible to continue in the study according to the following criteria:
- During pre-baseline treatment washout (before randomization): If treatment washout
is stopped at an IOP safety check visit during the pre-baseline treatment washout
the participant will be withdrawn except in cases where the fellow eye is eligible
for inclusion, in which case they may remain in the study.
- At baseline (before randomization): If the IOP in the study eye is outside the
specified range (18 mmHg & 40 mmHg inclusive) at baseline the participant would be
withdrawn except in cases where the fellow eye is eligible for inclusion, in which
case they may remain in the study.
- After cataract surgery (before randomization): If cataract surgery is complicated
or a physical pupil dilatation device is used during surgery (i.e. the procedure is
not an uncomplicated cataract surgery and IOL implantation) then the participant
will not be randomized and will be withdrawn except in cases where the fellow eye
is eligible for inclusion, in which case they may remain in the study.
Because enrolled participants may not meet the above criteria for continuing in the
study up to randomization, a significant percentage of participants are expected to exit
the study prior to qualifying for surgery and randomization.
Where participants are withdrawn prior to randomization because they do not meet the
above protocol defined criteria for remaining in the study:
- No further data will be collected from them for the study and they will not be
included in the final analysis.
- Safety events that occur prior to withdrawal will be recorded and any patient with
a safety event will not be exited from the study until the event is resolved or
stable.
- These patients will not be required to undergo further study related examinations.
Where a participant's treatment washout is stopped on an IOP safety check visit during
their treatment washout before the 1 or 2 year follow up visits (i.e. post
randomisation) then they will not be withdrawn but the post-washout data will be treated
as missing data.
Other grounds for early withdrawal from the study
Patients' participation in the study is entirely voluntary and each participant has the
right to withdraw from the study at any time.
In addition, the investigator may discontinue a participant from the study at any time
if the investigator considers it necessary for any reason, including:
- Ineligibility (either arising during the study or retrospectively, having been
overlooked at screening).
- Significant protocol deviation.
- An adverse event which results in the participant being unable to continue to
comply with study procedures.
- Disease progression which results in the participant being unable to continue to
comply with study procedures.
- If in the opinion of the investigator, the study procedures threaten the health or
well-being of the patient.
- Consent withdrawn or loss of capacity.
- Lost to follow up.
- Inability to continue
- At patient's request
Notification of a patient's early termination should be made immediately to the Sponsor
and documented on the appropriate CRF.
Where participants are withdrawn or choose to withdraw prior to randomisation any data
collected will not be included in the final analysis.
Patients who are withdrawn or choose to withdraw from the study will not be replaced
(the sample size includes an estimate of the likely number of participants who may be
withdrawn due to failure to meet the criteria for staying in the study up to
randomisation).
Where participants are withdrawn or choose to withdraw for any reason:
- The reason for withdrawal will be recorded.
- Data collected up to that point will be retained but no further data will be
collected.
- Decisions about their surgery and future clinical care after withdrawal will be
based on usual clinical practice. They will not be treated according to the study
protocol.
- Enrolled patients with an adverse event will be followed-up until resolution or
stabilisation of the event. If the participant is withdrawn due to an adverse event
the investigator will arrange for follow-up visits or telephone calls until the
adverse event has resolved or stabilised.
Participants lost to follow-up
Patients who cannot be successfully contacted after several attempts will be considered
lost to follow-up. Contact attempts will consist of the following:
- Three (3) documented phone calls and/or e-mails, followed by
- One (1) certified letter. Patients who are lost to follow-up will not be replaced;
however, patients may be recovered if contact is re-initiated at any time prior to
the patient's 2 years' follow-up visit.
Study procedures and data to be collected at each visit
Appendix A summarizes the procedures to be conducted at each study visit.
Baseline
Baseline assessments will be undertaken after 28-60 days treatment washout (i.e. at a
minimum 29 days from the commencement of treatment washout) and no more than 60 days
before surgery. The baseline visit may be an additional (i.e. non-routine) visit. All
tests and procedures performed at this visit are therefore additional procedures not
routine care. The procedures to be conducted at the baseline visit and the data to be
recorded are detailed below:
- Eligibility review including a check of all exclusion criteria to ensure that none
apply and baseline IOP criteria.
- Demographic details (date of birth and age, gender, ethnicity).
- Medical history/significant diagnoses
- Details of any ocular or other medications.
- Ophthalmic examination. The following procedures will be performed and the findings
recorded:
- Refraction/Auto-refraction
- Snellen Visual Acuity
- Slit Lamp Biomicroscopy (examination of the eye)
- Tonometry/IOP measurement (Goldmann applanation tonometry will be used to
measure IOP. The IOP measurement will be done after application of topical
anesthetic (eye drop) with fluorescein): IOP will be measured at two
time-points: 9AM +/- 2 hours and 11AM +/- 2 hours
- Pachymetry / central corneal thickness
- Gonioscopy
- Perimetry (Visual field test) (Humphrey Field Analyzer, HFA II, automated
white on white, 24-2 SITA-standard, Carl Zeiss Meditec Inc., Dublin, CA, USA)
- OCT scan of optic discs and macular
- Biometry: Anterior chamber depth and axial length
- Assessment and recording of any postoperative complications or other adverse
events.
- Assessment and recording of any need for supplemental medical therapy or additional
glaucoma surgery.
Day 0/Surgery
The procedures to be conducted on the day of surgery and the data to be recorded are
detailed below:
- Eligibility review including a check of all exclusion criteria to ensure that none
apply.
- Details of any ocular or other medications.
- Surgery:
- The surgery actually performed will be documented.
- Any other comments/events in relation to the surgery will also be documented.
- The phacoemulsification energy used during the cataract surgery will be
recorded.
- ECP procedure: The final power used and duration of surgery will be recorded,
and 'Pops' recorded.
- Randomization
- The reasons for withdrawal will be documented where patients are withdrawn from the
study before randomization because they do not meet all the intra-operative
eligibility criteria after cataract surgery.
- Ophthalmic examination. The following procedures will be performed and the findings
recorded:
- Snellen Visual Acuity
- Slit Lamp Biomicroscopy
- Tonometry/IOP measurement
- Assessment and recording of any intra-operative or postoperative complications or
other adverse events.
- Assessment and recording of any need for supplemental medical therapy or additional
glaucoma surgery.
Follow-up assessments The follow up period for the study is two years. Participants will
be followed up at clinic visits by members of the research team in a dedicated
ophthalmology research area or in the glaucoma clinic. The need for continued follow-up
and timely visits will be stressed to the patient throughout the study.
The schedule for follow up visits will be the same as would be the case for normal
clinical care. Data will be collected at 1 day (range 1-3 days), 1 week (range 5-9
days), 1 month (range 3-5 weeks), 3 months (range 10-14 weeks), 6 months (range 21-26
weeks), 1 year (range 337-407 days), and 2 years (range 680-728 days) post-operative.
Appendix A summarises the procedures to be conducted at each of the scheduled follow up
visits. The procedures to be conducted at the post-operative routine follow-up visits
and the data to be recorded are detailed below:
1. Day, 1 week, 1 month, 3 months and 6 months follow-up • Eligibility review
including a check of all exclusion criteria to ensure that none apply.
- Details of any ocular or other medications.
- Ophthalmic examination (as per usual care). The following procedures will be
performed and the findings recorded:
- Refraction/Auto-refraction
o Not performed at 1 day follow-up.
o Routine at 1 week and 1 month follow-up only.
o Additional non-routine procedure at 3 months and 6 months follow-up.
- Snellen Visual Acuity (as per usual care).
- Slit Lamp Biomicroscopy (as per usual care).
- Tonometry/IOP measurement (as per usual care).
- Perimetry (Visual field test) at 6 months follow-up only (as per usual
care). Not performed at 1 Day, 1 week, 1 month, and 3 months follow-up.
- Assessment of the success or failure of the surgery (at 6 months follow-up
only).
- Assessment and recording of any postoperative complications or other adverse
events.
- Assessment and recording of any need for supplemental medical therapy or
additional glaucoma surgery.
1. year and 2 years follow-up • Eligibility review including a check of all exclusion
criteria to ensure that none apply.
• Medical history/significant diagnoses (at 1 year follow-up only)
• Details of any ocular or other medications.
• Ophthalmic examination (as per usual care). The following procedures will be
performed and the findings recorded:
- Snellen Visual Acuity (as per usual care).
- Slit Lamp Biomicroscopy (as per usual care).
- Tonometry/IOP measurement: At 1 and 2 years follow-up IOP will be measured at two
time-points: 9AM +/- 2 hours and 11AM +/- 2 hours. At both visits the first IOP
measurement is as per usual care but the second IOP measurement is a non-routine
procedure).
- Gonioscopy (as per usual care).
- Perimetry (Visual field test) (as per usual care).
- OCT scan of optic discs and macular (as per usual care).
- Refraction/Auto-refraction (non-routine procedure at 1 and 2 years follow-up)
- Pachymetry / central corneal thickness (non-routine procedure at 1 and 2 years
follow-up)
- Biometry: Anterior chamber depth and axial length (non-routine procedure at 1
and 2 years follow-up).
• Assessment of the success or failure of the surgery.
• Assessment and recording of any postoperative complications or other adverse
events.
- Assessment and recording of any need for supplemental medical therapy or
additional glaucoma surgery.
- At the final visit (2 years post-operative) participants may be told
whether or not they had the ECP laser procedure as well as cataract
surgery.
8.1 Unscheduled visits and additional procedures Where participants attend any
unscheduled appointments the date and reason for the visit will be recorded on a
CRF.
Details of any additional procedures will also be recorded on a CRF (type of
procedure, date, reason for procedure being undertaken).
8.2 Definition of End of Trial The end of the trial is defined as the date of the
last follow-up visit for data collection of the last patient participating in the
study. At this point the REC will be informed that the study has been completed by
way of an end of study notification.
8.3 Criteria for the early termination of the trial It is not anticipated that
there will be any grounds for early termination of the study. All participants will
be eligible for phacoemulsification (cataract surgery). Both phacoemulsification
and the ECP laser procedures are already routinely performed. The ECP laser
procedure would not normally be done together with phacoemulsification, so for
those participants allocated to the phacoemulsification plus ECP arm, ECP will be
an extra non-routine procedure. However, the available evidence does not indicate
that there are substantially greater risks of intra- and post-operative
complications associated with combined phacoemulsification plus ECP compared with
phacoemulsification alone.
No study interventions will be undertaken during the follow up period. During
follow up the only deviation from normal care is that additional eye tests will be
performed at the 12 weeks and 1 and 2 years post-operative follow-up assessments
(routine appointments) and any participants still taking eye drops for their
glaucoma after the surgery will be asked to stop taking their eye drops (treatment
washout) for a minimum of 4 weeks before the 1 and 2 years post-operative follow-up
assessments. All of the eye tests that will be performed for the study are
routinely used in the Ophthalmology Department.
8.4 Source Data
The source documents from which participants' CRF data will be obtained (i.e. the
original documents, data, and records) will include:
- Patients' hospital records (from which medical history and previous and
concurrent medication may be summarised into the CRF).
- Glaucoma clinic notes.
- Data / printouts from eye tests conducted during the study and earlier. All
documents will be stored safely in confidential conditions. On all
study-specific documents, other than the signed consent, the participant will
be referred to by the study participant number/code, not by name.
9 Safety Reporting Also see APPENDIX B: Information with regards to Safety Reporting in
Non-CTIMP Research.
9.1 Definitions Adverse Event (AE) An adverse event (AE) is any untoward medical
occurrence in a patient (or other clinical investigation participant taking part in a
trial of a medical device) which does not necessarily have to have a causal relationship
with the device under investigation.
An AE can therefore be any unfavourable and unintended sign (including an abnormal
laboratory finding), symptom or disease temporally associated with the use of the
device, whether or not considered related to the device.
Adverse Device Effect (ADE) Adverse device effects (ADEs) are all untoward and
unintended responses to the medical device. The phrase 'responses to the medical device'
means that a causal relationship between the device under investigation and an AE is at
least a reasonable possibility (i.e. the relationship cannot be ruled out).
All cases judged by either the reporting medically qualified professional or the sponsor
as having a reasonable suspected causal relationship to the device qualify as a device
effect.
This also includes any event resulting from insufficiencies or inadequacies in the
instruction(s) for use or deployment of the device and includes any event that is a
result of a user error.
Serious Adverse Event (SAE):
A serious adverse event (SAE) is an adverse event that:
- Led to death
- Led to fetal distress, fetal death, congenital abnormality or birth defect. (Note
that pregnant women and women with child bearing potential, including if not using
contraceptives, are excluded.)
- Led to serious deterioration in the health of the patient that - resulted in a
life-threatening illness or injury, [NOTE: The term 'life-threatening' in the
definition of 'serious' refers to an event in which the participant was at risk of
death at the time of the event; it does not refer to an event which hypothetically
might have caused death if it were more severe.] - resulted in a permanent
impairment of a body structure or a body function,
- required in-patient hospitalisation or the prolongation of existing
hospitalisation, or
- resulted in medical or surgical intervention to prevent permanent impairment
to a body structure or a body function.
Other important medical events that may not result in death, are not life threatening,
or do not require hospitalisation, may be considered a serious adverse event when, based
upon appropriate medical judgement, the event may jeopardise the patient and may require
medical or surgical intervention to prevent one of the outcomes listed above.
To ensure no confusion or misunderstanding of the difference between the terms 'serious'
and 'severe', which are not synonymous, the following note of clarification is provided:
The term 'severe' is often used to describe the intensity (severity) of a specific event
(as in mild, moderate, or severe myocardial infarction). The event itself, however, may
be of relatively minor medical significance (such as severe headache). This is not the
same as 'serious', which is based on patient/event outcome or action criteria usually
associated with events that pose a threat to a participant's life or functioning.
Seriousness (not severity) serves as a guide for defining regulatory reporting
obligations.
Serious Adverse Device Effects (SADE):
A serious adverse device effect (SADE) is any untoward medical occurrence seen in a
patient that can be attributed wholly or partly to the device and which resulted in any
of the characteristics of, or led to a characteristic of, a serious adverse event.
A SADE is also any event that may have led to these consequences if suitable action had
not been taken or an intervention had not been made, or if circumstances had been less
opportune.
All cases are judged by either the reporting medically qualified professional or the
sponsor.
Unanticipated Adverse Device Effect (UADE):
A unanticipated adverse device effect (UADE) is any serious adverse device effect on
health or safety or any life-threatening problem or death caused by, or associated with
a device, if that effect, problem, or death was not previously identified in nature,
severity or degree of incidence in the investigational plan or application (including a
supplementary plan or application), or any other unanticipated serious problem
associated with a device that related to the rights, safety or welfare of the patient.
9.2 Reporting of Adverse Events All AE's occurring during the study observed by the
investigator or reported by the participant, whether or not attributed to the device
under investigation will be recorded on the CRF as specified in the protocol. All ADE's
will be recorded in the CRF.
The following information will be recorded: description, date of onset and end date,
severity, assessment of relatedness to device, other suspect drug or device and action
taken. Follow-up information should be provided as necessary.
The relationship of AEs to the device will be assessed by a medically qualified
investigator or the sponsor/manufacturer and will be followed up until resolution or the
event is considered stable.
All ADE that result in a participant's withdrawal from the study or are present at the
end of the study, should be followed up until a satisfactory resolution occurs.
Any pregnancy occurring during the clinical study will be recorded. 9.3 Reporting
Procedures for All Adverse Events For studies of CE marked devices all SAE/SADE/UADEs
need to be reported to the sponsor/legal representative (in this case Guy's and St
Thomas' NHS Foundation Trust) and the device manufacturer (BVI) and Guy's and St Thomas'
NHS Foundation Trust (GSTT) within one working day of the investigator team becoming
aware of them.
Reports of related and unexpected SAEs should be submitted to ethics within 15 days of
the Chief Investigator becoming aware of the event, using the SAE report form for
non-CTIMPs published on the NRES website.
All reporting to GSTT R&D should be by fax (0207 188 8330) giving as much information
about the incident as possible, and should be signed by the PI or Co-investigator. The
Guy's and St Thomas' NHS Foundation Trust (GSTFT) SADE reporting form should be used for
GSTT sponsored studies.
The GSTT R&D Department will undertake an initial review of the information and ensure
it is reviewed by GSTT R&D. Events will be followed up until resolution and any
appropriate further information will be sent by the research team in a timely manner.
Reporting to the MHRA will be done in liaison with the Chief Investigator and the
Manufacturer.
The Manufacturer has a legal obligation to report all events that need to be reported to
the Nominated Competent Authority immediately (without any unjustifiable delay) after a
link is established between the event and the device, but no more than:
- 2 days following the awareness of the event for Serious Public Health Threat.
- 10 days following awareness of the event for Death or unanticipated serious
deterioration in health.
- 30 days following the awareness of the event for all other event meeting the SAE
criteria.
9.4 Annual Reports In addition to the above reporting the Chief Investigator will submit
a progress/safety report to the REC and R&D once a year (or on request) throughout the
trial.
9.5 Criteria for the Termination of the Trial The study compares one off surgical
interventions that are currently in routine clinical use in the department. It is not
anticipated that any situation will arise that requires termination of the trial.
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