Trials / Completed
CompletedNCT05126173
DERM US and EU Validation Study
A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,111 (actual)
- Sponsor
- Skin Analytics Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Deep Ensemble for the Recognition of Malignancy (DERM) | An AI-based diagnosis support tool |
Timeline
- Start date
- 2022-03-15
- Primary completion
- 2022-08-19
- Completion
- 2022-09-15
- First posted
- 2021-11-18
- Last updated
- 2023-06-28
Locations
16 sites across 2 countries: United States, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05126173. Inclusion in this directory is not an endorsement.