The Development of a Surgical Localizing Aid Medical Device
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|ClinicalTrials.gov 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
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|
|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|
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
- Incision Length [ Time Frame: one year ]Measuring the reduction in incision length from using Target Tape
- 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.
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): NCT01300520
|Canada, British Columbia|
|The University of British Columbia Department of Orthopaedics|
|Vancouver, British Columbia, Canada, V5Z1L8|
|Principal Investigator:||Piotr Blachut, MD, FRCS(C)||The University of British Columbia Department of Orthopaedics|