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| ID | Type | Description | Link |
|---|---|---|---|
| B322201732457 | Other Identifier | Belgian registration number | |
| 80M0675 | Other Identifier | FAMHP Belgium |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barco digital dermatoscope device images | Device | Images of skin lesion taken with the Barco dermatoscope by site team member | ||
| Reference standard dermatoscope device images | Device | Images of skin lesion taken with a standard dermatoscope device (as part of standard care) |
| Measure | Description | Time Frame |
|---|---|---|
| Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI | 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 | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of new device to standard dermoscopy | Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be considered for enrollment in the study when they have a lesion that is accessible to the Barco Digital Dermatoscope, are able to give informed consent and are over 18 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Marjan Garmyn, Prof. Dr. | UZ / KU Leuven | Principal Investigator |
| Lieve Brochez, Prof. Dr. | UZ Gent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Ghent | 9000 | Belgium | |||
| UZ / KU Leuven |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D017437 | Skin and Connective Tissue Diseases |
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| Leuven |
| 3000 |
| Belgium |