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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,028
Lesions enrolled in the study are biopsied to confirm histopathology
Users are blinded to the DermaSensor Device result
Mayo Clinic
Rochester, Minnesota, United States
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
Time frame: Day 1
Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
Time frame: Day 1
Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%
Time frame: Day 1
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