NCT03754426

A Prospective, Pilot Evaluation of Device Equivalence

Validation of MolecuLight Phoenix Prototypes in Clinic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: MolecuLight Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	Fluorescence Imaging Device	Hand-held, real-time fluorescence imaging device

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-01-02
• Completion: 2019-01-02
• First posted: 2018-11-27
• Last updated: 2019-12-03

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study