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A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. 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 |
|---|---|---|---|---|
| Digital dermoscopy | Device | Acquire skin images with a new digital dermatoscope |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the new device in its normal conditions of use | The outcome will be measured by a questionnaire with performance-related questions for clinicians to answer about a set of images from the collected database. A Likert-based scale will be used for the answers: from highly agree to highly disagree. | 6 months |
| Usability of the new device | The outcome will be measured by a questionnaire with usability-related questions for clinicians. | 1 month |
| Safety of the new device in its normal conditions of use | The number of adverse events will be reported to assess safety of the device. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Develop a database of skin images with the new device with metadata and histopathology of excised lesions | The outcome of the secondary objective will be an anonymized database of digital skin lesion images and corresponding metadata and a set of high quality images amenable to clinician evaluation. | 1 year |
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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 new digital dermatoscope and are able to give informed consent (guardian in case of patients under 18 years).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologic Surgery Center of Washington LLC | Chevy Chase | Maryland | 20815 | United States | ||
| Silver Falls Dermatology |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Salem |
| Oregon |
| 97302 |
| United States |