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

Sponsored by DermaSensor, Inc.

About this trial

Last updated 2 years ago

Study ID

CSP-18-0002

Status

Completed

Type

Observational

Placebo

No

Accepting

22+ Years
All Sexes

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Men or women of any ethnic group aged 22 and older

2. Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy

3. Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)

Exclusion Criteria

1. Lesion < 2.5mm in diameter or > 15mm in diameter

2. Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)

3. Lesion on area of crust, psoriasis, eczema or similar skin condition

4. Lesion has erosion and/or ulceration with no area >2.5mm intact

5. Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)

6. Lesion in which the device tip cannot be placed entirely within the border of the targeted area

7. Lesion located on acral skin (e.g. sole or palms)

8. Lesion located within 1 cm of the eye

9. Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention

10. Lesion located on mucosal surfaces (e.g. genitals, lips)

11. Lesion located on acute sunburn

12. Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy

13. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent