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Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer (DermScan)

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ClinicalTrials.gov Identifier: NCT03818620
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Barco NV

Brief Summary:
This is a multicenter prospective observational clinical investigation with a medical device. The purpose of this study is to develop and validate of a new type of digital dermatoscope with automatic decision support algorithms. 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.

Condition or disease Intervention/treatment
Skin Cancer Skin Diseases Device: Barco digital dermatoscope device images Device: Reference standard dermatoscope device images

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer


Intervention Details:
  • Device: Barco digital dermatoscope device images
    Images of skin lesion taken with the Barco dermatoscope by site team member
  • Device: Reference standard dermatoscope device images
    Images of skin lesion taken with a standard dermatoscope device (as part of standard care)


Primary Outcome Measures :
  1. Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI [ Time Frame: 3.5 years ]
    Database of multispectral images of potential skin cancer lesions acquired with the Barco device together with clinical information (e.g. age, gender, history of skin cancer, histopathology diagnosis) and matched standard images using medical photography


Secondary Outcome Measures :
  1. Comparison of new device to standard dermoscopy [ Time Frame: 2 years ]
    Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be considered for enrollment in the study when they have a lesion that is accessible to the Barco Digital Dermatoscope, are able to give informed consent and are over 18 years old.
Criteria

Inclusion Criteria:

  • The patient has a lesion that is accessible to the Barco Digital Dermatoscope
  • Patient gives informed consent
  • Men or women of any ethnic group aged ≥ 18 years

Exclusion Criteria:

  • Men or women of any ethnic group aged < 18 years
  • Patients not willing or able to read, understand and sign the study-specific informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818620


Contacts
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Contact: Hannah Manssens 056 26 2609 ext +32 hannah.manssens@barco.com

Locations
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Belgium
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Sofie Mylle    093326568 ext +32    sofie.mylle@uzgent.be   
Dermatologie Handelskaai Completed
Kortrijk, Belgium, 8500
UZ / KU Leuven Recruiting
Leuven, Belgium, 3000
Contact: Sofie Van Kelst    016 37 21 17 ext +32    sofie.vankelst@kuleuven.be   
Sponsors and Collaborators
Barco NV
Investigators
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Principal Investigator: Marjan Garmyn, Prof. Dr. UZ / KU Leuven
Principal Investigator: Lieve Brochez, Prof. Dr. UZ Gent
Principal Investigator: Erwin Suys, Dr. Dermatologie Handelskaai Kortrijk

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Responsible Party: Barco NV
ClinicalTrials.gov Identifier: NCT03818620     History of Changes
Other Study ID Numbers: CI-PROT-0010
B322201732457 ( Other Identifier: Belgian registration number )
80M0675 ( Other Identifier: FAMHP Belgium )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Skin Neoplasms
Skin Diseases
Neoplasms by Site
Neoplasms