Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04836676 |
| Other study ID # |
CREX-006 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2021 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
April 2021 |
| Source |
Carponovum AB |
| Contact |
Anders Grönberg, MD, PhD |
| Phone |
+46708378626 |
| Email |
anders[@]carponovum.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In colorectal surgery, hand suturing and stapling are routine methods for performing
intestinal anastomoses, and these methods appear to be similar in terms of clinical safety.
Despite several years of experience with surgical procedures as well as improvements to the
medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis
after colorectal surgery remain a significant challenge for surgeons. A frequency of
anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In
addition, preoperative radiotherapy has been shown to increase the risk of anastomotic
leakage even further.
The methods that are used today to detect leakages are unfortunately inaccurately and limited
to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and
CT-scans. These clinical signs and parameters usually become apparent several days after
onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a
significant cause of increased morbidity of complications and mortality in patients, but also
associated with increased risk of local recurrence and poor prognosis. Moreover, when
reoperation is required to fix the leakage, a permanent stoma may be made at the level of the
sigmoid colon and this procedure impacts live quality of patients negatively.
Based on the above considerations, a novel, adaptive anastomotic method has been developed by
CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking
Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal
ends and validate the anastomosis, with function of Extract samples for analysis and conduct
X-ray through connected catheters.
The newly developed adaptive anastomotic medical devices, C-REX LapAid Cath and C-REX
RectoAid Cath are easy to use, with unique possibility to control the anastomosis during and
after surgery. The previous successful pre-market data support a successful CE marking of the
devices, which encourages a post-market clinical follow-up (post CE mark clinical study) in
patients undergoing colonic resection to collect post-market data of C-REX LapAid Cath and
C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis.
Description:
OVERALL DESIGN:
The study is a post-market multicentre non-randomized controlled study. In each
investigational site, the investigational personnel shall start with colonic resections,
first 10 patients. When surgeons feel confident using the device and ward personal feel
confident treating the patient postoperatively, they will initiate rectal resections.
Eligible patients for C-REX LapAid Cath are those requiring resection of the left colon
(descending colon and sigmoid) or above the upper rectum (> 15 cm above the anal rim) due to
malign or benign disease. Eligible patients for C-REX RectoAid Cath are those requiring
resection of the rectum due to malign or benign disease. The proximal limit is upper rectum
(< 15 cm above the anal rim) and the distal limit is the anal sphincter.
Patients will be enrolled in the study after they have provided informed consent, having
undergone physical examination and been found to meet inclusion criteria. Bowel cleansing
prior surgery should be performed according to local routines. The intestinal resection and
anastomosis with the investigational devices, i.e. C-REX LapAid Cath or C-REX RectoAid Cath,
shall be performed in line with standard procedure of proctocolectomy during hospitalization.
Surgeons can utilize catheters that allow monitoring of the anastomosis during and after
surgery.
The healing period is expected to be approximately 10 ± 2 days. The short-term implant
detaches via necrosis on the inner part of the intestinal surface and is expelled the natural
way. The patient can be discharged before expelling of the short-term implant upon
investigator's discretion.
The patients will be followed up according to local procedure subsequently. The LARS score
shall be assessed at 12 months, and healthcare utilization shall be assessed at 12 months
postoperatively.
SUBJECTS:
The aim of this study is to collect post-market data of C-REX LapAid Cath and C-REX RectoAid
Cath for the purpose of clinical evaluation and risk analysis. No control group is included
in this study.
Considering that similar anastomotic devices have been used in clinic for decades, the study
will include about 200 subjects from at least 3 different sites/hospitals. In which, colonic
resections shall be applied in 100 subjects, and recta resections in another 100 subjects.
The device used is either C-REX LapAid Cath or C-REX RectoAid Cath.
QUALITY CONTROL:
1. Authorization to apply investigational devices:
According to CarpoNovum's regulation, clinical investigators must be authorized to
perform adaptive anastomosis with C-REX LapAid Cath or C-REX RectoAid Cath by performing
at least one tutor-led surgery on pigs and at least one train-in surgery on patients
with the trainer. When the clinical investigator is authorized to use the
investigational devices, he or she receives a certificate.
2. Investigation site selection:
Investigation sites will be identified to participate in the study based on current
experience, referrals from the principle investigator, and training in the use of the
investigational devices according to the procedure of surgeon accreditation, and in
accordance with ICH GCP guidelines and ISO 14155. It is expected that the surgeons will
adhere to and follow protocol of performing adaptive anastomosis provided in the IFUs,
and relevant study documents.
3. Monitoring:
To ensure that the study is appropriately conducted, there is a need for on-site
monitoring before, during and after the clinical study. Remote monitoring without
visiting the site may be performed as well. The study will be monitored by CarpoNovum or
its authorized representatives in accordance the internal procedures of CarpoNovum. The
frequency of the visit will be determined by the sponsor and scheduled based on
enrolment and the number of active follow-up visits at each site.
The responsible monitor will evaluate and summarize the results of each monitoring visit
in a written report. The reports will be sent to the sponsor and the principal clinical
investigators.
4. Traceability and device accountability:
The investigational devices stored in the investigation site in a locked cabin are only
accessible to investigation personnel.
The size of the device used in surgery should be recorded in CRF, the Patient Record Label on
the device should be pasted on CRF as well. If more than one set of investigational devices
are opened during surgery, all Patient Record Labels should be pasted on CRF and reasons for
why the devices have been opened during surgery should be recorded.
After surgery, the information of used or opened devices should be noted in Device
Accountability. The used investigational devices or opened but not used devices, together
with expelled short-term implants should be collected and saved in the investigation site.
All components of devices, no matter if they have been used or not, as well as expelled
short-term implants if possible, should be hand over to the sponsor when the study is
finished. No component of investigational devices should be disposed or lost.
DOCUMENTATION AND DATA MANAGEMENT:
The following information should be clearly documented in medical record of subjects:
- That the subject is informed about the study and that the subject has signed the
informed consent forms.
- That the subject is participating in the study; the identification code for the subject,
the name of the study, and the study number.
- Which treatment the study refers to.
- Name of clinical investigator.
- All AEs and device deficiencies.
The personal data obtained in the course of the study, in accordance with the informed
consent, and in particular clinical findings are subjected to confidentiality. All generated
and processed data during the study are protected by subject's identification code. Subjects
will also provide his/her written approval for concerned investigation personnel,
representatives of the sponsor, monitor and the medical inspection authority, Swedish or
foreign, to obtain access to subjects' medical records, to compare them to collected data or
reported information. This approval will be granted with reservations that information
concerning subjects that become available is not pursued further. Subjects must also give
his/her written approval that the study results that concern the subjects can be used in
reporting on the study as a whole, provided that no records are pursued further.
For each subject enrolled, regardless of medical device initiation, a CRF must be completed
and signed by corresponding study personnel. This applies to those subjects who fail to
complete the study. If a subject withdraws from the study, the reason must be noted on CRF.
Data and information of subjects derived from the study, for instance medical records,
imagine reports, surgical notes etc. are considered as source data. To ensure that all data
are complete and correct, source data verification (SDV) will be confirmed by the monitor.
Comments in CRF should be made with a ballpoint pen with permanent ink in paper based CRF.
In both paper-based CRF and eCRF, if comments are missing in CRF, reasons for this must be
stated. No questions, squares, fields or similar should be left without comments.
The responsible clinical investigator is obliged to keep the subject identification lists
with the subject's identification code and identity in a safe place at the investigation
site, accessible only to the investigation personnel. These source data and subject
identification lists will be saved for 10 years after the close of the study at the medical
institution.
EARLY STUDY TERMINATION:
CarpoNovum reserves the right to terminate a non-preforming site. Reasons for considering
early termination or suspension of an individual site may include, but are not limited to:
- Non-compliance with study protocol or failure to comply with government or local
regulations.
- Failure to submit data in a timely manner.
- Failure to comply with or act upon findings.
- Failure to enrol an adequate number of subjects.
- Other reasons mentioned in the PMCIP, including that other investigation sites have
enrolled a sufficient number of evaluable subjects which meets the statistical
requirements
CarpoNovum reserves the right to discontinue the study at any time due to, but not limited
to:
- Strategic considerations of CarpoNovum.
- Force majeure event which results that the study cannot continue.
Upon early termination of the study, the sponsor will notify each investigator immediately at
the time of such a decision. Formal documentation will be provided to the Swedish Ethical
Review Authority and investigation sites. After such a decision, the investigators must
contact all participating subjects to notify them of this decision and its impact on their
follow-up.
STATISTICAL CONSIDERATION:
Basic demographic and other baseline characteristics will be analysed for all patients.
Summary statistics (arithmetic mean and standard deviation / median and interquartile range,
minimum and maximum for quantitative variables, as appropriate) will be presented for the
total study population. Frequency tables for qualitative data will be provided. Any deviation
from specified statistical plan will be in addition to "per protocol" analysis and will be
reported as such.
Any deviations from the specified statistical analysis plan will be described in the study
report.
Analysis populations:
ITT (Intention to treat) analysis set - all included researchers who have undergone surgery
so that they have been exposed to a risk of leakage according to the primary study point,
including those who withdraw or are excluded during the operation or are excluded during
follow-up. The primary analysis is based on this analysis set.
Safety analysis set - all researchers who have undergone surgery. Safety endpoints are
analyzed with this analysis set.
Per protocol analysis set - all researchers who completed the study without protocol
deviations. As a secondary analysis, the primary analysis is also performed on this analysis
set.
