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Clinical Trials/NCT03818620
NCT03818620
Active, not recruiting
Not Applicable

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

Barco NV2 sites in 1 country3,000 target enrollmentJune 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin Cancer
Sponsor
Barco NV
Enrollment
3000
Locations
2
Primary Endpoint
Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2017
End Date
April 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Barco NV
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Comparison of new device to standard dermoscopy(2 years)

Study Sites (2)

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