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OpenTrials
Active, Not Recruiting

NCT Number: NCT03818620

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Barco digital dermatoscope device images

Device

Images of skin lesion taken with the Barco dermatoscope by site team member

Reference standard dermatoscope device images

Device

Images of skin lesion taken with a standard dermatoscope device (as part of standard care)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Barco NV

Industry

Registry information

Official study title

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

Acronym: DermScan

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2019
Registry last updated
Feb 5, 2025

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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