Development and Validation of a New Digital Dermatoscope in the United States

Study Overview
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Brief Summary
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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.

Official Title
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Development and Validation of a New Digital Dermatoscope in the United States

Conditions
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Skin Cancer

Intervention / Treatment
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* Device: Digital dermoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Male or Female, aged less than 18 years, with informed consent of their legally authorized representative. Patient presenting with any visible skin lesion for dermatologist review on a body site amenable to optimal photographic imaging. Able and willing to comply with all study requirements. Patient with a skin lesion that is clinically diagnosed by a dermatologist as benign, malignant or a suspicious skin lesion requiring excisional biopsy for histological diagnosis. Exclusion Criteria: Patients aged under 18 years old where the legally authorized representative is unable or unwilling to provide their informed consent. Patients unable to provide informed consent. Skin lesions in an anatomical site which is not suitable for photography including hair-obscured site, subungual lesion or inaccessible mucosal site. Lesion is at a site where previous surgery was undertaken.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Digital dermoscopy|Acquire skin images with a new digital dermatoscope|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |