Actively Recruiting
DermaSensor Postmarket Surveillance Study
Led by DermaSensor, Inc. · Updated on 2024-10-31
396
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
DermaSensor Postmarket Surveillance Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women of any ethnic group aged 40 and older
- Primary skin lesion suspicious for melanoma
- Patient is willing and able to read, understand, and sign the informed consent form (ICF)
You will not qualify if you...
- Lesion is not accessible to the DermaSensor device handheld unit and tip (e.g., inside ears, under nails)
- Lesion is on areas with psoriasis, eczema, acne, or similar inflammatory skin conditions that prevent proper device placement
- Lesion is greater than 15mm in diameter at the widest point
- Lesion has a targeted area less than 2.5mm in diameter where device tip cannot be fully placed within lesion border
- Lesion lacks a contiguous area of at least 2.5mm due to ulceration, erosion, or liquid discharge (e.g., blood)
- Lesion is covered by crust or scale that cannot be cleared to expose at least 2.5mm of intact skin free of crust, ulceration, erosion, or liquid discharge
- Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter)
- Lesion is not completely cleared of dermoscopy oils, makeup, sunscreen, topical solutions, powders, markings, or staining treatments (e.g., iodine)
- Lesion is located on acral skin (e.g., sole or palms)
- Lesion is located within 10mm of the eye
- Lesion is on or next to scars, previously biopsied areas, or areas with past surgical intervention
- Lesion is located on mucosal surfaces (e.g., genitals, lips)
- Lesion is located in an area with acute sunburn
- Dementia or other neurological, physical, or psychological limitations that prevent signing informed consent or completing required follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Velocity
New Smyrna Beach, Florida, United States, 32168
Actively Recruiting
2
West Clinical Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
Research Team
J
Justin Frazier, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SCREENING
Number of Arms
2
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