The Development of a Surgical 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. Identifier: NCT01300520
Recruitment Status : Terminated (Enough surgeon use to validate the usefulness of the device)
First Posted : February 21, 2011
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):
Aeos Biomedical Inc.

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. 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 or disease Intervention/treatment Phase
Femoral Fracture Tibial Fracture Device: Target Tape Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incision Length [ Time Frame: one year ]
    Measuring the reduction in incision length from using Target Tape

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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 identifier (NCT number): 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

Responsible Party: Aeos Biomedical Inc. Identifier: NCT01300520     History of Changes
Other Study ID Numbers: TT-1
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 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