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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-07

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Skin Cancer Skin Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Barco digital dermatoscope device images

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

Intervention Type DEVICE

Reference standard dermatoscope device images

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No