DermaSensor Postmarket Surveillance Study
DermaSensor, Inc.
Summary
The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men or women of any ethnic group aged 40 and older 2. Primary skin lesion suspicious for melanoma 3. Patient is willing and able to read, understand, and sign the informed consent form (ICF) Exclusion Criteria: 1. Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.) 2. Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion. 3. Lesion is greater than 15mm in diameter at the widest point. 4. Lesion has a ta…
Interventions
- DeviceScan with elastic scattering spectroscopy device to assess risk of malignancy
Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare suspicious lesion signature to that of previously scanned lesions with known benign or malignant pathology
Locations (2)
- VelocityNew Smyrna Beach, Florida
- West Clinical ResearchMorehead City, North Carolina