Trials / Completed
CompletedNCT04368247
Skin Fluorescent Imaging (SFI) System in Patients With Nevi
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Orlucent, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.
Detailed description
The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Skin Fluorescent Imaging | Application of reagents, then imaging and scoring |
Timeline
- Start date
- 2020-08-10
- Primary completion
- 2023-06-30
- Completion
- 2023-08-31
- First posted
- 2020-04-29
- Last updated
- 2025-08-07
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04368247. Inclusion in this directory is not an endorsement.