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

Completed

• Conditions: Skin Cancer

• Registration Number: NCT04047316
• Lead Sponsor: Barco NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Study Start: 2019-08-27
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the new device in its normal conditions of use	1 year	The number of adverse events will be reported to assess safety of the device.
Performance of the new device in its normal conditions of use	6 months	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.
Usability of the new device	1 month	The outcome will be measured by a questionnaire with usability-related questions for clinicians.

Secondary Outcome Measures

Name	Time	Method
Develop a database of skin images with the new device with metadata and histopathology of excised lesions	1 year	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.

Trial Locations

Locations (2)

Dermatologic Surgery Center of Washington LLC; 🇺🇸 Chevy Chase, Maryland, United States

Silver Falls Dermatology; 🇺🇸 Salem, Oregon, United States