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The Development of a Surgical Localizing Aid Medical Device

This study has been terminated.
(Enough surgeon use to validate the usefulness of the device)
Information provided by (Responsible Party):
Aeos Biomedical Inc. Identifier:
First received: February 18, 2011
Last updated: February 3, 2017
Last verified: February 2017

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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    Measuring the reduction in incision length from using Target Tape

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

  • Procedure Time Savings [ Time Frame: One Year ]
    Measuring the time savings of using Target Tape during the procedure.

Enrollment: 5
Actual Study Start Date: March 2011
Study Completion Date: December 2013
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
Without target tape in the procedure
Device: Target Tape
Comparing procedures using Target Tape against procedures not using Target Tape

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01300520

Canada, British Columbia
The University of British Columbia Department of Orthopaedics
Vancouver, British Columbia, Canada, V5Z1L8
Sponsors and Collaborators
Aeos Biomedical Inc.
Principal Investigator: Piotr Blachut, MD, FRCS(C) The University of British Columbia Department of Orthopaedics
  More Information

Responsible Party: Aeos Biomedical Inc. Identifier: NCT01300520     History of Changes
Other Study ID Numbers: TT-1
Study First Received: February 18, 2011
Last Updated: February 3, 2017

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

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Tibial Fractures
Wounds and Injuries
Leg Injuries processed this record on July 21, 2017