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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
Sponsor:
Information provided by (Responsible Party):
Target Tape

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Neoplasms Spinal Fractures Device: Target Tape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reduction in Fluoroscopy Exposure [ Time Frame: 6 months ]
    Measuring the decreased amount of fluoroscopy radiation exposed to the medical staff and the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects who may have allergies to medical skin adhesives

Information from the National Library of Medicine

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


Contacts
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Contact: Nicholas Seto, BComm 7788681544 nick.seto@Target-tape.com
Contact: Colin O'Neill, BASc 7787732530 colin.oneill@Target-Tape.com

Sponsors and Collaborators
Target Tape
Investigators
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Principal Investigator: Jin W Tee, MD, FRACS University of British Columbia
Publications:
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Responsible Party: Target Tape
ClinicalTrials.gov Identifier: NCT02603874    
Other Study ID Numbers: H15-02787
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Target Tape:
Fluoroscopy
Spinal Fusion
Wrong Level Surgery
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Fractures
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases