Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the use of the SPY Elite System to assess real-time tissue perfusion of lower extremity amputation sites and to develop parameters to predict healing of amputations at the time of surgery.

This is a pilot study to see if the Spy Elite System is capable of recording accurate measurements on amputation sites to allow some correlation to healing. If this study shows promise for the device, the investigators would plan a larger study in which the data would be assessed in the operating room at time of acquisition and revision performed if needed based on the findings.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Collaborators: Novadaq Technologies Inc.; Novadaq Technologies ULC, now a part of Stryker

Criteria

Inclusion Criteria:

• All patients >= 18 years of age requiring Below Knee Amputation (BKA) or Above Knee Amputation (AKA) cared for by the vascular surgery service will be assessed for eligibility.

Exclusion Criteria:

• Subjects with a history of allergies to iodides or iodinated contrast agents, pregnant or nursing women, subjects who are unable to provide consent, and prisoners will be excluded.