A Prospective, Pilot Evaluation of Device Equivalence
- Conditions
- Wound
- Registration Number
- NCT03754426
- Lead Sponsor
- MolecuLight Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Subjects (inpatient/outpatient) presenting with a wound
- Wound size less than 15 cm in length
- 18 years or older
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concordance 2 months Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Judy Dan Research and Treatment Centre
🇨🇦North York, Ontario, Canada