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Active, not recruitingNCT03818620DermScanUpdated Feb 5, 2025

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

An observational study in Skin Cancer and Skin Diseases, sponsored by Barco NV. Active, not recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Barco NV · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Skin Cancer
  • Skin Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • DeviceBarco digital dermatoscope device images

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

  • DeviceReference standard dermatoscope device images

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

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What researchers measure

Primary outcomes

  1. Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI

    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

    Time frame: 3.5 years

Secondary outcomes

  1. Comparison of new device to standard dermoscopy

    Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)

    Time frame: 2 years

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Study locations

2 sites
  • UZ Gent
    Gent, 9000, Belgium
  • UZ / KU Leuven
    Leuven, 3000, Belgium
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03818620
Lead sponsor
Barco NV
Responsible party
Sponsor
First posted
Jan 28, 2019
Start date
Jun 7, 2017
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Feb 5, 2025

Study contacts

Marjan Garmyn, Prof. Dr.
principal investigator · UZ / KU Leuven
Lieve Brochez, Prof. Dr.
principal investigator · UZ Gent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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