Clinical trial NCT06666790: DermaSensor Postmarket Surveillance Study
Official title: DermaSensor Postmarket Surveillance Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma, Skin
Keywords: medical device
skin cancer detection
elastic scattering spectroscopy
Lead sponsor: DermaSensor, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 396
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Enrolled lesions are assessed without and then with the device result as basis for study investigator decision to biopsy or monitor a potentially malignant lesion.
Primary purpose: SCREENING

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


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

Primary outcomes:
measure: Device Sensitivity
timeFrame: 39 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Smyrna Beach
country: United States
facility: Velocity
state: Florida
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
Study officials:
affiliation: DermaSensor, Inc.
name: Gary Slatko, MD, MBA
role: STUDY_CHAIR
References: