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

NCT02440295 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Wound Healing
  • Lower Extremity Amputation
  • Above Knee Amputation
  • Below Knee Amputation

Interventions

PROCEDURE

Lower Extremity Amputation

DEVICE

SPY Elite Imaging System

The SPY Elite Imaging System is an adjunctive tool that can be used to assess tissue perfusion in real-time and provides surgeons with information that may change their operative plan before leaving the operating room. (http://novadaq.com/products/spy-elite) The system is comprised of two components, the first is the Spy Elite Kit, which is a single-use package containing one 25 mg vial of indocyanine green, one 10 ml vial of sterile Water for injection, and one SPY Elite sterile drape. The second component to the system is the SPY Elite Device which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, an HD video camera captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field.

DRUG

Indocyaine Green

Indocyaine Green (ICG) is a non-nephrotoxic fluorescent imaging agent with a half-life of 2.5-3 minutes that is administered intravenously.

Sponsors & Collaborators

  • Novadaq Technologies ULC, now a part of Stryker

    collaborator INDUSTRY

  • Spectrum Health Hospitals

    lead OTHER

Principal Investigators

  • Robert F. Cuff, MD · Spectrum Health Hospitals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440295 on ClinicalTrials.gov