The Development of a Vertebra Localizing Aid Medical Device
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 13, 2015
November 1, 2015
5 months
November 5, 2015
November 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Fluoroscopy Exposure
Measuring the decreased amount of fluoroscopy radiation exposed to the medical staff and the patient
6 months
Study Arms (2)
Target Tape
EXPERIMENTALIncluding target tape in the procedure
Control
NO INTERVENTIONWithout target tape in the procedure
Interventions
Comparing procedures using Target Tape against procedures not using Target Tape
Eligibility Criteria
You may qualify if:
- Surgical spine procedures involving the use of medical imaging to determine the vertebra site (ex. fusions, tumor removals, fracture repairs, discectomies). The medical imaging scans may include planar X-rays, fluoroscopy, CT or MRI scans
- Able and willing to consent
You may not qualify if:
- Subjects who may have allergies to medical skin adhesives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Target Tapelead
Related Publications (1)
Kim KD, Li W, Galloway CL. Use of a radiopaque localizer grid to reduce radiation exposure. Ann Surg Innov Res. 2011 Aug 9;5:6. doi: 10.1186/1750-1164-5-6.
PMID: 21827694BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin W Tee, MD, FRACS
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 13, 2015
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
November 13, 2015
Record last verified: 2015-11