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OpenTrials
Completed

NCT Number: NCT03754426

A Prospective, Pilot Evaluation of Device Equivalence

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.

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Key information

Conditions

Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Judy Dan Research and Treatment Centre

North York, Ontario, M2R 1N5, Canada

About this study

Patients (n = 50) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects (inpatient/outpatient) presenting with a wound
  • Wound size less than 15 cm in length
  • 18 years or older

Exclusion criteria

  • Treatment with an investigational drug within 1 month before study enrolment
  • Subjects with recent (<30 days) biopsy or curettage of target wound
  • Subjects with wounds that cannot be completely imaged by study device due to anatomic location
  • Unable or unwilling to consent

Treatment and study plan

Fluorescence Imaging Device

Device

Hand-held, real-time fluorescence imaging device

Primary outcomes

  1. Concordance

    Time frame: 2 months

    Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices

Sponsors and collaborators

Lead sponsor

MolecuLight Inc.

Industry

Registry information

Official study title

Validation of MolecuLight Phoenix Prototypes in Clinic

Acronym: Equivalence

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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