Clinical Trials

Inclusion Criteria:

• Men or women of any ethnic group aged 22 and older.
• Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy.
• Patient is willing and able to read, understand and sign the ICF.

Exclusion Criteria:

• Lesion < 2.5mm in diameter or > 15mm in diameter.Lesion surface not accessible (e.g., inside ears, under nails, completely covered by a crust or scale)
• Lesion on area of crust, psoriasis, eczema or similar skin condition.
• Lesion has erosion and/or ulceration with no area > 2.5mm intact.
• Lesion has foreign matter (e.g., tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions).
• Lesion in which the device tip cannot be placed entirely within the border of the targeted area.
• Lesion located on acral skin (e.g., sole or palms).
• Lesion located within 1 cm of the eye.
• Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
• Lesion located on mucosal surfaces (e.g., genitals, lips).
• Lesion located on acute sunburn.
• Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy.
• Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent.