A Prospective, Pilot Evaluation of Device Equivalence

Wound Clinical Trial

— Equivalence  

Official title:

Validation of MolecuLight Phoenix Prototypes in Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754426
• Other study ID #: 18-009
• Status: Completed
• Start date: November 26, 2018
• Est. completion date: January 2, 2019

Study information

• Verified date: November 2019
• Source: MolecuLight Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• Fluorescence Imaging Device
Hand-held, real-time fluorescence imaging device

Locations

Country	Name	City	State
Canada	Judy Dan Research and Treatment Centre	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
MolecuLight Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance	Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices	2 months