NCT03967405

A Prospective Evaluation of Clinical Equivalence Between iX and PID

A Prospective Evaluation of Clinical Equivalence Between i:X and PID

• Status: Unknown
• 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 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many 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 2 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 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	MolecuLight PID	Hand-held, real-time fluorescence imaging device

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2019-05-30
• Last updated: 2020-03-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study