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

June 18, 2020 updated by: Barco NV
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Usability of the new device
Time Frame: 1 month
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
Time Frame: 1 year
The number of adverse events will be reported to assess safety of the device.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barco NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 27, 2019

Primary Completion (ACTUAL)

April 15, 2020

Study Completion (ACTUAL)

April 15, 2020

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (ACTUAL)

August 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-PROT-0029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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