Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
- Conditions
- Skin DiseasesSkin Cancer
- Registration Number
- NCT03818620
- Lead Sponsor
- Barco NV
- Brief Summary
This is a multicenter prospective observational clinical investigation with a medical device. The purpose of this study is to develop and validate of a new type of digital dermatoscope with automatic decision support algorithms. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- The patient has a lesion that is accessible to the Barco Digital Dermatoscope
- Patient gives informed consent
- Men or women of any ethnic group aged ≥ 18 years
- Men or women of any ethnic group aged < 18 years
- Patients not willing or able to read, understand and sign the study-specific informed consent form
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI 3.5 years Database of multispectral images of potential skin cancer lesions acquired with the Barco device together with clinical information (e.g. age, gender, history of skin cancer, histopathology diagnosis) and matched standard images using medical photography
- Secondary Outcome Measures
Name Time Method Comparison of new device to standard dermoscopy 2 years Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)
Trial Locations
- Locations (2)
UZ Gent
🇧🇪Gent, Belgium
UZ / KU Leuven
🇧🇪Leuven, Belgium