DERM US and EU Validation Study
Trial ID or NCT#
NCT05126173
Status
NOT RECRUITING
Purpose
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.
Official Title
A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Willing and able to give informed consent for participation in the study, - Male or Female, aged 18 years or above, - Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer, To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations: located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, located in an area of visible scarring or tattooing. - In the Investigator's opinion, able and willing to comply with all study requirements.
Exclusion Criteria:
- - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Contact us to find out if this trial is right for you.
Contact
Niki Saruwatari
+1 650-723-4309
View on ClinicalTrials.gov
