Study of the DermaSensor Device to Detect Melanoma in Suspicious Skin Lesions Postmarket Surveillance in Adults Age 40 and Older

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 devices input, and another where the devices 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 devices 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.

DermaSensor Postmarket Surveillance Study