DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer

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.

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 Informed Consent Form (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