The Development of a Vertebra Localizing Aid Medical Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02603874|
Recruitment Status : Unknown
Verified November 2015 by Target Tape.
Recruitment status was: Not yet recruiting
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Neoplasms Spinal Fractures||Device: Target Tape||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Development of a Vertebra Localizing Aid Medical Device|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Target Tape
Including target tape in the procedure
Device: Target Tape
Comparing procedures using Target Tape against procedures not using Target Tape
No Intervention: Control
Without target tape in the procedure
- Reduction in Fluoroscopy Exposure [ Time Frame: 6 months ]Measuring the decreased amount of fluoroscopy radiation exposed to the medical staff and the patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603874
|Contact: Nicholas Seto, BComm||7788681544||nick.seto@Target-tape.com|
|Contact: Colin O'Neill, BASc||7787732530||colin.oneill@Target-Tape.com|
|Principal Investigator:||Jin W Tee, MD, FRACS||University of British Columbia|