DermaSensor Postmarket Surveillance Study

DermaSensor, Inc.

Status: Enrolling

Conditions: Melanoma, Skin

Treatments: Device: Scan with elastic scattering spectroscopy device to assess risk of malignancy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06666790

CSP-24-0002

Details and patient eligibility

About

The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.

Enrollment: 396 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 targeted area less than 2.5mm in diameter where the DermaSensor device tip cannot be placed entirely within the border of the targeted area of the lesion.
5. Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
6. Lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood).
7. Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
8. Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine).
9. Lesion is located on acral skin (e.g., sole or palms).
10. Lesion is located within 10mm of the eye.
11. Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
12. Lesion is located on mucosal surfaces (e.g. genitals, lips).
13. Lesion is located in an area with acute sunburn.
14. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and/or completing any required follow-up visits

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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396 participants in 2 patient groups

Clinical assessment only

No Intervention group

Description:

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output

Clinical assessment with device output

Experimental group

Description:

Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output

Treatment:

Device: Scan with elastic scattering spectroscopy device to assess risk of malignancy