BridgeMD
New treatment option for Melanoma, Skin
Official title DermaSensor Postmarket Surveillance Study
ClinicalTrials.gov ID: NCT06666790
What this study is testing
- What it's testing
- The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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 likely can't join if
- Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
- Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement...
- Lesion is greater than 15mm in diameter at the widest point.
- 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...
- Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
- 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...
See the full eligibility criteria
- 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)
- Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
- Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
- Lesion is greater than 15mm in diameter at the widest point.
- 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.
- Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
- 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...
- Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
- 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).
- Lesion is located on acral skin (e.g., sole or palms).
- Lesion is located within 10mm of the eye.
- Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any 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 neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and/or completing any required follow-up visits
The study team makes the final eligibility decision.
Where it's taking place
- New Smyrna Beach, Florida, United States
- Morehead City, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Smyrna Beach, Florida, United States; Morehead City, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.