The Development of a Surgical Localizing Aid Medical Device
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Incision Length [ Time Frame: one year ] [ Designated as safety issue: Yes ]Measuring the reduction in incision length from using Target Tape
- 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 |
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| 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 |
| 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) | |
| 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 Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 21, 2013