AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

DermaSensor Postmarket Surveillance Study

RecruitingNAAges 40 Years - anyAllDermaSensor, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • Scan with elastic scattering spectroscopy device to assess risk of malignancy
๐Ÿ“

Where

2 sites
Velocity
New Smyrna Beach, United States
West Clinical Research
Morehead City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy