NCT06666790 DermaSensor Postmarket Surveillance Study
| NCT ID | NCT06666790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DermaSensor, Inc. |
| Condition | Melanoma, Skin |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2027-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 396 participants in total. It began in 2024-10-08 with a primary completion date of 2027-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Gary Slatko, MD, MBA
STUDY CHAIR
DermaSensor, Inc.
Frequently Asked Questions
Who can join the NCT06666790 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Melanoma, Skin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06666790 currently recruiting?
Yes, NCT06666790 is actively recruiting participants. Contact the research team at justin.frazier@dermasensor.com for enrollment information.
Where is the NCT06666790 trial being conducted?
This trial is being conducted at New Smyrna Beach, United States, Morehead City, United States.
Who is sponsoring the NCT06666790 clinical trial?
NCT06666790 is sponsored by DermaSensor, Inc.. The principal investigator is Gary Slatko, MD, MBA at DermaSensor, Inc.. The trial plans to enroll 396 participants.
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