Evaluating the DermaSensor device for detecting melanoma

DermaSensor Postmarket Surveillance Study

This study is testing a new device to see if it can accurately detect skin lesions that might be melanoma in people aged 40 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 396 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: DermaSensor, Inc. (industry)
• Locations: 2 sites (New Smyrna Beach, Florida and 1 other locations)
• Trial ID: NCT06666790 on ClinicalTrials.gov

What this trial studies

This study aims to assess the sensitivity of the DermaSensor device in detecting skin lesions that may indicate melanoma. Participants will undergo scanning with the device, which utilizes elastic scattering spectroscopy to evaluate the risk of malignancy in suspicious skin lesions. The study focuses on individuals aged 40 and older who have primary skin lesions that are concerning for melanoma. The findings will help determine the effectiveness of this medical device in real-world settings.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 40 and older with primary skin lesions suspicious for melanoma.

Not a fit: Patients with lesions that are inaccessible to the device or affected by inflammatory skin conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance early detection of melanoma, leading to better patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies using advanced imaging techniques for skin cancer detection have shown promise.

Eligibility criteria

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

Where this trial is running

New Smyrna Beach, Florida and 1 other locations

• Velocity — New Smyrna Beach, Florida, United States (RECRUITING)
• West Clinical Research — Morehead City, North Carolina, United States (RECRUITING)

Study contacts

• Study coordinator: Justin Frazier, MS

Conditions: Melanoma, Skin, medical device, skin cancer detection, elastic scattering spectroscopy