Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02603874 |
| Other study ID # |
H15-02787 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
November 5, 2015 |
| Last updated |
November 10, 2015 |
| Start date |
January 2016 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
November 2015 |
| Source |
Target Tape |
| Contact |
Nicholas Seto, BComm |
| Phone |
7788681544 |
| Email |
nick.seto[@]Target-tape.com |
| Is FDA regulated |
No |
| Health authority |
Canada: Health Canada |
| Study type |
Interventional
|
Clinical Trial Summary
The current method of incision localization in many surgical procedures requires a doctor to
reference a medical image, such as an X-ray, to judge where on the body an incision should
be made. However, the precise information of the scan is not shown on the patient's skin.
Surgeons commonly use palpation to locate the point of incision. They may feel for the area
directly or find landmarks under the skin and estimate the location from there. This can be
challenging due to the difficulty of feeling and distinguishing each vertebra, especially
for new surgeons, since palpation is a skill derived through experience.
If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the
fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer
to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and
the patient to radiation. Many fluoroscopic images may be required in a single procedure.
The purpose of this study is to test the efficacy and benefits of a new medical device that
will aid in radiological localization. The hypothesized outcome would be smaller incisions,
faster localization and a reduction in fluoroscopy use.
By identifying the efficacy of this new medical device, "Target Tape", there is the
potential outcome of making smaller incisions, faster localization, a reduction in
fluoroscopy use and a reduced chance in surgical error and the associated costs.
Target Tape is a non invasive device that is in a grid format that is placed against the
subject's skin. The grid pattern will then appear on the medical imaging scan. The medical
practitioner can correlate device grid on the body to the medical scan image to make their
incisions in more accurate locations.
Description:
Consent must first be obtained from the prospective patient before Target Tape can be
incorporated into the procedure. When a target procedure is scheduled to occur, the surgeon
will first determine if Target Tape would be appropriate to use. The procedure will need to
be able to integrate Target Tape into it using the Method of Use described above. The
decision to then pursue the procedure will be under the discretion of the medical
practitioner and consent from the patient. Depending on the procedure, the medical
practitioner may need to communicate to the OR or the radiology department to integrate
Target Tape into their protocol, since the practitioner making the incisions(s) may not
always be the one applying it. Examples of spine procedures that may utilize Target Tape may
be stabilization of fractures, tumor removals, fusions, discectomies and kyphoplasties. .
Once the procedure is determined to be appropriate to accommodate Target Tape, the medical
practitioner will approach the prospective patient and explain how the device will be
utilized, the benefits and potential risks associated with it, and answer any questions the
patient may have. A representative from Target Tape Inc may be on hand to aid with this
process and may also observe said procedure to record the necessary information. The consent
form will then be signed and Target Tape will then be utilized during the procedure.
The methodology of creating an outcome measure will occur over 2 stages with multiple steps
in each stage:
Stage I: Proof of Concept
1. Specify measurement goals
2. Proof of Concept Testing
3. Item generation
4. Item reduction
Stage 2: Verification 5. Verification Testing 6. Reliability 7. Validity 8. Interpretability
(i) Subjects (ii) Involved Groups (iii) Data Collection (iv) Statistics
Stage 1: Proof of Concept
1. Measurement goals
The specific measurement goals are to verify specific procedures that benefit from
Target Tape. This serves as primary evidence, beyond the initial feedback and opinions
of medical professionals. Based on the benefits to the procedures, significant
performance variables will be determined that can be measured in Stage 2 testing. The
significant performance variables may be either qualitative or quantitative:
- Ease of use (surgeon opinion)
- Usefulness (surgeon opinion)
- Time analysis
- Incision length
- Fluoroscopy use
Other variables that may need to be collected are certain subject characteristics (ie.
age, gender, height, weight and skin pigmentation). These variables help control for
the effects of variable skin characteristics that may affect the performance of Target
Tape.
Based upon interviews with medical professions such as surgeon and radiologists,
initial target procedures include stabilization of fractures, tumor removals, fusions,
discectomies and kyphoplasties.
This research is intended to be a multi participant study and may include a variety of
different spine physicians who are interested in utilizing the device in their
procedures. The overall method of use and testing remains consistent between the
various participants.
2. Proof of Concept Testing When a target procedure is scheduled to occur, the surgeon
will first determine if Target Tape would be appropriate to use. The procedure will
need to be able to integrate Target Tape into it using the Method of Use described
above. The decision to then pursue the procedure will be under the discretion of the
medical practitioner and consent from the patient. Depending on the procedure, the
medical practitioner may need to communicate to the OR or the radiology department to
integrate Target Tape into their protocol, since the practitioner making the
incisions(s) may not always be the one applying it. Once the procedure is determined to
be appropriate to accommodate Target Tape, the medical practitioner will approach the
prospective patient and explain how the device will be utilized, the benefits and
potential risks associated with it, and answer any questions the patient may have. The
consent form will then be signed and Target Tape will then be utilized during the
procedure.
3. Variable generation Item generation will be conducted in two stages. First, a list of
items will be created from the current outcome. The items will be grouped according to
the domains of: ease of use, device limitations, patient characteristics, time
analysis, incision length and fluoroscopy use. Second, this list will be distributed to
the surgeons/medical practitioners who have used the device and any missing items will
be included. It is anticipated that up to 10 procedures would have used the device.
4. Variable reduction The list of items generated in the step above will be administered
to doctors who will be asked to rate the items according to importance. Any items that
are deemed insignificant will be removed from the list. The objective of the item
reduction step is to find variables that are important to patients, doctors, and the
hospital. Furthermore, a definitive list of target procedures will be chosen, with
procedures of no observed benefits taken off the list.
Stage 2: Verification
5. Verification Testing Subject to the testing results of Stage 1, there will be a set of
significant performance variables determined for each respective target procedure. The
significant variables may include time in the OR, incision length and fluoroscopy
exposure. The purpose of Stage 2 would be to verify the significant variables for each
procedure. Exclusion criteria would be created based upon the outcome of Stage 1.
Target Tape would then be randomly utilized in the procedures, with controls for who is
performing the procedure and patient characteristics (such as gender, age, weight,
height and skin pigmentation). Observation of the significant performance variable
occurs for all the procedures. The significant variables may be highly dependent upon
the medical practitioner; therefore, the sample size will be related to the number of
procedures the respective practitioner performs in a given amount of time. Stage 2 may
not be a necessary step for the initial development of Target Tape; due to the
simplicity of the device as well as qualitative factors, the cost-benefit analysis may
not necessarily require a lengthy statistical study.
6. Reliability Reliability refers to the consistency of the tool; the tool being the
criteria and testing to measure the significant performance variables. The device that
will be used will be the same design throughout Stage 2.
7. Validity Validity refers to how well an instrument (i.e. criteria and testing) measures
what it claims to measure. The different types of validity are: face, content,
construct and criterion validity. Face validity ensures that the significant
performance variables make sense and will be ensured throughout the creation of the
criteria by involving surgeons, radiologists and patients. Content validity is the
extent to which an instrument covers a representative sample of the domain in question.
Again this will be ensured during the creation of the tool by involving surgeons,
radiologists and patients. Construct validity assesses the factors that can affect
ratings. Construct validity will also be assessed by looking for floor and ceiling
effects. Criterion validity may be assessed, and is the extent to which the utilization
of Target Tape is predictive of surgical outcomes (i.e. incision lengths, radiation
exposure, and procedure times).
8. Interpretation Quantitative measurements are measured on an absolute scale: incision
lengths measured in millimeters, procedure times in seconds, and fluoroscopy exposure
in the number of 'shots' as well as the time of live exposure in seconds (if possible).
Controls for patient characteristics will be recorded in absolute values, i.e. 37
years, 5'8" 160 lbs. In the interpretation and analysis, these controls may be grouped.
There are also measures of the surgeon's opinion on the qualitative 'ease of use' and
qualitative 'usefulness'. This would be a of 10, with the 10 mark representing the best
possible score. In this case, zero would be difficult to use or can see no usefulness,
respectively. These scores would be converted into percentages. They can be interpreted
to find relative usefulness across various surgical procedures, as well as the effects
of independent variables (i.e. physical controls).
(i) Subjects The population for which Target Tape is designed for is an individual
undergoing a medical procedure in which a medical imaging scan is utilized to assist
with incision localization. These medical imaging scans may include X-ray, fluoroscopy,
CT or MRI. Depending on the nature of the procedure, the scan(s) may be done
preoperative or intraoperative. The surgeon may use the scan image in conjunction with
palpation to determine the incision site. Examples of possible procedures include
stabilization of fractures, tumor removals, fusions, discectomies and kyphoplasties.
Although the above conditions represent procedures that can occur in patients of any
age, the population to which this study will be directed is those who would not be
allergic to any medical adhesives, medical skin inks, and/or copper metal.
The designated surgeon or medical practitioner will carry out subject recruitment at an
appropriate time before preoperative imaging or before the operation. Those who agree
may be asked to complete the consent form at that same time.
Sample size
Stage 1:
1-2 Spinal surgeons up to 10 patients
The number of medical practitioners in each type of procedure may fluctuate. The number
of patients may vary depending on the relative magnitude of the observations and
feedback from the medical practitioners.
Stage 2:
The sample sizes for each segment of this stage corresponds to sample sizes used to
create outcome measures in the different populations. After Stage 1 has been completed,
the sample sizes for Stage 2 will be assessed and a statistical model will be created
at that time. A preliminary estimate would require 5 times the sample size of per
procedure of Stage 1 to be a sufficient.
