Skin Cancer, Skin Diseases
Conditions
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.
Interventions
DEVICEBarco digital dermatoscope device images
Images of skin lesion taken with the Barco dermatoscope by site team member
DEVICEReference standard dermatoscope device images
Images of skin lesion taken with a standard dermatoscope device (as part of standard care)
Sponsors
Barco NV
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Belgium
Outcome results
None listed