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A Prospective, Pilot Evaluation of Device Equivalence

NCT03754426 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-12-03

No results posted yet for this study

Summary

Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Conditions

  • Wound

Interventions

DEVICE

Fluorescence Imaging Device

Hand-held, real-time fluorescence imaging device

Sponsors & Collaborators

  • MolecuLight Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Linden, MD · Judy Dan Research and Treatment Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2019-01-02
Completion
2019-01-02
FDA Device
Yes

Countries

  • Canada

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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 NCT03754426 on ClinicalTrials.gov