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

NCT04047316 | Completed FDA Device

• 1 other identifier: CI-PROT-0029
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Develop a database of skin images with the new device with metadata and histopathology of excised lesions

  1 year

Interventions

Digital dermoscopy DEVICE

Acquire skin images with a new digital dermatoscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barco NV: lead

Study Sites (2)

Dermatologic Surgery Center of Washington LLC

Chevy Chase, Maryland, 20815, United States

Location

Silver Falls Dermatology

Salem, Oregon, 97302, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: August 27, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

US (2)