DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
NCT06690086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1028
Last updated 2024-12-09
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
- collaborator OTHER
-
DermaSensor, Inc.
lead INDUSTRY
Principal Investigators
-
Stephen P Merry, MD, MPH · Mayo Clinic
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-17
- Primary Completion
- 2021-12-09
- Completion
- 2021-12-09
- FDA Device
- Yes
Countries
- United States
Study Locations
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