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Pilot Study to Assess the Use of Spy Elite for Assessment of Amputation Healing
NCT02440295 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02440295
The ClinicalTrials.gov registry entry for NCT02440295 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health West, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02440295 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02440295?
This trial is sponsored by Corewell Health West, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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