A Prospective, Pilot Evaluation of Device Equivalence

MolecuLight

Status: Completed

Conditions: Wound

Treatments: Device: Fluorescence Imaging Device

Study type: Observational

Funder types: Industry

Identifiers

NCT03754426

18-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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