A Prospective, Pilot Evaluation of Device Equivalence (Equivalence)

Validation of MolecuLight Phoenix Prototypes in Clinic

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.

Study Overview

• Status: Completed
• Conditions: Wound
• Intervention / Treatment: Device: Fluorescence Imaging Device

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M2R 1N5
      • Judy Dan Research and Treatment Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with chronic wounds

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance	Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices	2 months

Collaborators and Investigators

• Sponsor: MolecuLight Inc.
• Investigators: Principal Investigator: Ron Linden, MD, Judy Dan Research and Treatment Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): January 2, 2019
• Study Completion (Actual): January 2, 2019

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 29, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 18-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No