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

Barco

Status: Completed

Conditions: Skin Cancer

Treatments: Device: Digital dermoscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT04047316

CI-PROT-0029

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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.