Trials / Completed
CompletedNCT05196880
Biofilm Correlation and Validation
A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- MolecuLight Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.
Conditions
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
- 2022-02-15
- Primary completion
- 2022-05-15
- Completion
- 2023-11-08
- First posted
- 2022-01-19
- Last updated
- 2024-03-15
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05196880. Inclusion in this directory is not an endorsement.