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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Scan with elastic scattering spectroscopy device to assess risk of malignancy
DeviceElastic 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
Treatment groups
396 Participants
are divided into 2 treatment groupsGroup A: Clinical assessment onlyNo intervention 0 interventions
Group B: Clinical assessment with device outputExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Sensitivity
Time frame
39 monthsSponsors and contacts
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Source ClinicalTrials.gov