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The Development of a Surgical Localizing Aid Medical Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Aeos Biomedical Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Aeos Biomedical Inc.
ClinicalTrials.gov Identifier:
NCT01300520
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Femoral Fracture
Tibial Fracture
Device: Target Tape

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Development of a Surgical Localizing Aid Medical Device and the Determination and Analysis of Significant Variables

Resource links provided by NLM:


Further study details as provided by Aeos Biomedical Inc.:

Primary Outcome Measures:
  • Incision Length [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Measuring the reduction in incision length from using Target Tape


Secondary Outcome Measures:
  • Reduction in Fluoroscopy Exposure [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Measuring the decreased amount of fluoroscopy radiation exposed to the medical staff and the patient.

  • Procedure Time Savings [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Measuring the time savings of using Target Tape during the procedure.


Estimated Enrollment: 250
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Target Tape
Including target tape in the procedure
Device: Target Tape
Comparing procedures using Target Tape against procedures not using Target Tape
Other Name: Target Tape
No Intervention: Control
Without target tape in the procedure
Device: Target Tape
Comparing procedures using Target Tape against procedures not using Target Tape
Other Name: Target Tape

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300520

Contacts
Contact: Nicholas D Seto, BCom 778-868-1544 nick.seto@gmail.com
Contact: Colin S O'Neill, BASc 778-773-2530 c.s.oneill@gmail.com

Locations
Canada, British Columbia
The University of British Columbia Department of Orthopaedics Not yet recruiting
Vancouver, British Columbia, Canada, V5Z1L8
Contact: Nicholas Seto, BCom    778-868-1544    nick.seto@gmail.com   
Contact: Colin S O'Neill, BASc    778-773-2530    c.s.oneill@gmail.com   
Principal Investigator: Piotr Blachut, MD, FRCS(C)         
Sponsors and Collaborators
Aeos Biomedical Inc.
Investigators
Principal Investigator: Piotr Blachut, MD, FRCS(C) The University of British Columbia Department of Orthopaedics
  More Information

Publications:
Responsible Party: Nicholas Seto, Aeos Biomedical Inc
ClinicalTrials.gov Identifier: NCT01300520     History of Changes
Other Study ID Numbers: TT-1
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by Aeos Biomedical Inc.:
Fluoroscopy
Femoral fracture
Tibial fracture
Spinal Fusion

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Tibial Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014