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

• Sponsor: Barco NV (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03818620
• Collaborator: (none)
• Enrollment: 3,000
• Locations: 2
• Anticipated Duration (Months): 66.8
• Patients Per Site: 1500
• Patients Per Site Per Month: 22.5

Study Details

Study Description

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	Phase
Skin Cancer; Skin Diseases	Device: Barco digital dermatoscope device images; Device: Reference standard dermatoscope device images

Study Design

• Study Type: Observational
• Anticipated 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: Jun 7, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI [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 [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Gent	Gent		Belgium	9000
2	UZ / KU Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Barco NV

Investigators

• Principal Investigator: Marjan Garmyn, Prof. Dr., UZ / KU Leuven
• Principal Investigator: Lieve Brochez, Prof. Dr., UZ Gent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barco NV
• ClinicalTrials.gov Identifier: NCT03818620
• Other Study ID Numbers: CI-PROT-0010; B322201732457; 80M0675
• First Posted: Jan 28, 2019
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Skin Neoplasms; Skin Diseases

Study Results

No Results Posted as of Jul 20, 2022