Trials / Completed
CompletedNCT06690086
DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,028 (actual)
- Sponsor
- DermaSensor, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.
Detailed description
A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Lesion biopsy | Lesions enrolled in the study are biopsied to confirm histopathology |
| DEVICE | DermaSensor Device Use | Users are blinded to the DermaSensor Device result |
Timeline
- Start date
- 2020-08-17
- Primary completion
- 2021-12-09
- Completion
- 2021-12-09
- First posted
- 2024-11-15
- Last updated
- 2024-12-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06690086. Inclusion in this directory is not an endorsement.