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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047316
• Other study ID #: CI-PROT-0029
• Status: Completed
• Start date: August 27, 2019
• Est. completion date: April 15, 2020

Study information

• Verified date: June 2020
• Source: Barco NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Digital dermoscopy
Acquire skin images with a new digital dermatoscope

Locations

Country	Name	City	State
United States	Dermatologic Surgery Center of Washington LLC	Chevy Chase	Maryland
United States	Silver Falls Dermatology	Salem	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Barco NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Usability of the new device	The outcome will be measured by a questionnaire with usability-related questions for clinicians.	1 month
Primary	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	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