RecruitingNot ApplicableNCT06666790

DermaSensor Postmarket Surveillance Study


Sponsor

DermaSensor, Inc.

Enrollment

396 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring how well a handheld skin scanning device called DermaSensor performs in real-world use after it has already been approved. The device uses light-based technology to help detect whether a suspicious skin spot might be melanoma. **You may be eligible if...** - You are 40 years or older, of any background - You have a skin spot that your doctor suspects could be melanoma - The spot is accessible and no larger than 15 mm wide **You may NOT be eligible if...** - The spot is in a hard-to-reach area (e.g., under nails, inside ear) - The spot is on skin affected by psoriasis, eczema, or acne - The spot is too small (under 2.5 mm), ulcerated, crusted, tattooed over, or covered with makeup or sunscreen that can't be removed - The spot is on the palms, soles, near the eye, on mucous membranes, or in an area of prior surgery - You have dementia or a condition preventing you from consenting or attending follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEScan with elastic scattering spectroscopy device to assess risk of malignancy

Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare suspicious lesion signature to that of previously scanned lesions with known benign or malignant pathology


Locations(2)

Velocity

New Smyrna Beach, Florida, United States

West Clinical Research

Morehead City, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06666790


Related Trials