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NCT02440295 · ClinicalTrials.gov registry record
Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
A clinical trial of Wound Healing and Lower Extremity Amputation, sponsored by Corewell Health West.
- Completed
- Registry status
- 18
- Enrollment target
- 1
- Study location
NCT02440295: Completed study of Wound Healing and Lower Extremity Amputation, sponsored by Corewell Health West.
NCT02440295 is a study of Wound Healing and Lower Extremity Amputation that has completed, run by Corewell Health West. The registered enrollment target is 18 participants, below the 56-participant average among 11 other Wound Healing trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02440295, a study of Wound Healing and Lower Extremity Amputation, has completed, sponsored by Corewell Health West.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome variable includes wound healing at 30 days and intra-operative imaging of amputation sites using the SPY Elite System.
Conditions Studied
Interventions
- PROCEDURE Lower Extremity Amputation
- DEVICE SPY Elite Imaging System
- DRUG Indocyaine Green
Study Locations (1)
Michigan
- Spectrum Health Hospitals - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-12 |
What the finished NCT02440295 record still lists
NCT02440295 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 56-participant average among 11 other Wound Healing trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Wound Healing appearing as the primary indexed condition, and to 3 interventions - of which Lower Extremity Amputation is the first listed.
NCT02440295 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02440295 about?
NCT02440295 is a clinical study titled "Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing". 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 rec...
What is the current status of trial NCT02440295?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2015-05. Estimated completion is 2016-12.
What conditions does trial NCT02440295 study?
This clinical trial studies the following conditions: Wound Healing, Lower Extremity Amputation, Above Knee Amputation, Below Knee Amputation.
What interventions are being tested in trial NCT02440295?
The interventions under investigation include: Lower Extremity Amputation (PROCEDURE), SPY Elite Imaging System (DEVICE), Indocyaine Green (DRUG).
Who is sponsoring clinical trial NCT02440295?
This trial is sponsored by Corewell Health West, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02440295 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02440295's enrollment target sits among peer trials
18 12th of 11 the lowest of 11 other Wound Healing trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wound Healing trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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