NCT06682923

MolecuLightDX Measurement Feature Clinical Validation

Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: MolecuLight Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.

Detailed description

The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.

Conditions

• Wounds
• Wound of Skin

Interventions

Type	Name	Description
DEVICE	MolecuLight DX Imaging Device	The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.

Timeline

• Start date: 2024-10-23
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

2 sites across 1 country: Canada