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CompletedNCT04047316Updated Jun 18, 2020

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

An observational study in Skin Cancer, sponsored by Barco NV. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2020-06-18.

Sponsored by Barco NV · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study 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.

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Conditions studied

  • Skin Cancer

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • DeviceDigital dermoscopy

    Acquire skin images with a new digital dermatoscope

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. Usability of the new device

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

    Time frame: 1 month

  3. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

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Study locations

2 sites
  • Dermatologic Surgery Center of Washington LLC
    Chevy Chase, Maryland 20815, United States
  • Silver Falls Dermatology
    Salem, Oregon 97302, United States
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Registry details

Key details

Study ID
NCT04047316
Lead sponsor
Barco NV
Responsible party
Sponsor
First posted
Aug 6, 2019
Start date
Aug 27, 2019
Primary completion
Apr 15, 2020
Completion
Apr 15, 2020
Last update
Jun 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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