DermaSensor Postmarket Surveillance Study
ConditionMelanoma, Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorDermaSensor, Inc.
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Scan with elastic scattering spectroscopy device to assess risk of malignancy
Treatment groups
396 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov