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Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients

NCT03611361 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2024-04-17

No results posted yet for this study

Summary

This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.

Conditions

  • Amputation Wound
  • Peripheral Arterial Disease

Interventions

DEVICE

SpectralMD DeepView Wound Imaging System 2.0

The DeepView is an imaging device which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a machine learning (ML) algorithm to categorize microvascular blood flow and provide a quantitative assessment for selection of tissue healing.

Sponsors & Collaborators

  • Baylor Research Institute

    collaborator OTHER

  • SpectralMD

    lead INDUSTRY

Principal Investigators

  • Dennis Gable, MD · Baylor College of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-18
Primary Completion
2020-07-31
Completion
2020-12-31
FDA Device
Yes

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 NCT03611361 on ClinicalTrials.gov