Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.
Details
Lead Sponsor:
Spectrum Health Hospitals
Collaborators:
Novadaq Technologies Inc. Novadaq Technologies ULC, now a part of Stryker