DermaSensor Postmarket Surveillance Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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)
Locations
United States
Florida
Velocity
RECRUITING
New Smyrna Beach
North Carolina
West Clinical Research
RECRUITING
Morehead City
Contact Information
Primary
Justin Frazier, MS
justin.frazier@dermasensor.com
508-776-0044
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2027-09-10
Participants
Target number of participants: 396
Treatments
No_intervention: Clinical assessment only
Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output
Experimental: Clinical assessment with device output
Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output
Related Therapeutic Areas
Sponsors
Leads: DermaSensor, Inc.