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OpenTrials
Completed

NCT Number: NCT04047316

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital dermoscopy

Device

Acquire skin images with a new digital dermatoscope

Primary outcomes

  1. Performance of the new device in its normal conditions of use

    Time frame: 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.

  2. Usability of the new device

    Time frame: 1 month

    The outcome will be measured by a questionnaire with usability-related questions for clinicians.

  3. Safety of the new device in its normal conditions of use

    Time frame: 1 year

    The number of adverse events will be reported to assess safety of the device.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Barco NV

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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