Actively Recruiting
DermaSensor Postmarket Surveillance Study for Melanoma Detection Using Elastic Scattering Spectroscopy Device
Led by DermaSensor, Inc. · Updated on 2024-10-31
396
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the sensitivity of the DermaSensor device and investigators in detecting melanoma from suspicious skin lesions. The study focuses on men and women aged 40 and older who have skin lesions that may be melanoma, assessing how well the device and clinical exam can identify concerning lesions. Participants are divided into two groups: one where primary care investigators assess suspicious lesions and decide to biopsy without the device's input, and another where the device's output informs the biopsy decision. The DermaSensor uses elastic scattering spectroscopy, which analyzes light reflected from the lesion to compare it to known benign or malignant patterns. During the study, participants will have their skin lesions examined either with or without the device's assistance. Researchers will measure how sensitive the device is in detecting melanoma over 39 months. Patients will be monitored through the study period to observe the diagnostic process and outcomes, ensuring proper follow-up and safety.
CONDITIONS
Brief 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
- Willing and able to read, understand, and sign the informed consent form
You will not qualify if you...
- Lesion not accessible to the DermaSensor device handheld unit and tip (e.g., inside ears, under nails)
- Lesion on areas with psoriasis, eczema, acne, or similar inflammatory skin conditions that prevent device tip placement
- Lesion larger than 15mm in diameter at widest point
- Lesion with targeted area less than 2.5mm where device tip cannot be placed entirely within lesion border
- Lesion with no contiguous area of at least 2.5mm due to ulceration, erosion, or liquid discharge
- Lesion 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 obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter)
- Lesion not completely cleared of dermoscopy oils, makeup, sunscreen, topical solutions, powders, markings, or staining treatments
- Lesion located on acral skin such as soles or palms
- Lesion within 10mm of the eye
- Lesion on or adjacent to scars, previously biopsied areas, or past surgical intervention sites
- Lesion located on mucosal surfaces (e.g., genitals, lips)
- Lesion located in an area with acute sunburn
- Dementia or neurologic, physical, or psychological limitation preventing consent or follow-up completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 39 months
Participants who undergo routine care are observed while lesions suspicious for melanoma are assessed clinically, with or without the elastic scattering spectroscopy device.
Follow-up visits as part of routine clinical assessment
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
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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