The Development of a Surgical Localizing Aid Medical Device

February 3, 2017 updated by: Aeos Biomedical Inc.

The Development of a Surgical Localizing Aid Medical Device and the Determination and Analysis of Significant Variables

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. The following factors further complicate palpation: overweight patients, foreign bodies that are difficult to feel for under the skin, fractures with little displacement, or locations under dense muscles. These difficulties are compounded for new surgeons, since palpation is a skill derived through experience.

In many circumstances the surgeon only needs to know where to insert the tool or place the incision - they do not necessarily need to know the depth of the area of interest. 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.

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 or ruler format that is placed against the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan. Standard surgical skin ink is then used to place these markings in a defined pattern on the skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can correlate these skin markings to the medical scan image to make their incisions in more accurate locations.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed 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 procedures that may utilize Target Tape may be stabilization of fractures, interlocking screw insertions during tibia or femur nailings, breast biopsies, foreign body removals, thoracic and spinal surgeries. 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 Aeos Biomedical 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

6) Statistical Analysis Sample size

Stage 1:

3 Orthopaedic surgeons, up to 10 patients, per procedure type

3 Spinal surgeons up to 10 patients, per procedure type

3 Plastic surgeons up to 10 patients, per procedure type

2 Thoracic surgeons up to 5 patients, per procedure type

2 Radiologists up to 10 patients, per procedure type

The number of medical practitioners in each type of procedure may fluctuate. Furthermore, this is not a definitive list of specialties. It is foreseeable that a greater variety of procedures from other specialties may be included in the proof of concept testing. Moreover, 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 per procedure within Stage 1 to be a sufficient.

Variable generation - There is no statistical analysis at this step. It is anticipated that up to 10 procedures would have used the device with at least two different doctors.

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.

Verification Testing It is anticipated that 5 times the sample size for each procedure will occur in this step. Subject to the testing results of Stage 1, there will be a set of significant performance variables determined for each respective target procedure. Target Tape would then be randomly utilized in the procedures, with controls for who is performing the procedure and patient characteristics. Observation of the significant performance variable occurs for all the procedures

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1L8
        • The University of British Columbia Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be undergoing a radiological imaging, such as planar X-ray, fluoroscopy, CT or MRI

Exclusion Criteria:

  • Subjects who may have allergies to medical skin adhesives, medical skin inks or copper metal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Target Tape
Including target tape in the procedure
Other: Control
Without target tape in the procedure
Comparing procedures using Target Tape against procedures not using Target Tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incision Length
Time Frame: one year
Measuring the reduction in incision length from using Target Tape
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Fluoroscopy Exposure
Time Frame: one year
Measuring the decreased amount of fluoroscopy radiation exposed to the medical staff and the patient.
one year
Procedure Time Savings
Time Frame: One Year
Measuring the time savings of using Target Tape during the procedure.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Piotr Blachut, MD, FRCS(C), The University of British Columbia Department of Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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