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NCT05517889 Clinical Trial

Repeatability and Stability of Healthy Skin Features on OCT

Artificial Intelligence Clinical Trial

Official title:
Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05517889
Other study ID # 2022-3219
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A test-retest study on the stability and repeatability of healthy skin features on OCT

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least18 years of age Exclusion Criteria: - Unable to sign informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Optical coherence tomography
Optical coherence tomography is a non-invasive scanner which generates real-time in-vivo images of the skin and its adnexal structures. Images are generated by light-interferometry.

Locations
Country Name City State
Netherlands Maastricht UMC+ Maastricht Limburg

Sponsors (2)
Lead Sponsor Collaborator
Maastricht University Medical Center Maastricht University (Precision medicine The D-lab)

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Repeatable hand-crafted radiomics-features The number of HRFs that are repeatable in a test-retest setting Interval of 10 minutes
Primary Interclass Correlation Coefficient (ICC) Intraclass Correlation Coefficient (ICC) will be used to assess the correlation and repeatability of the HRFs resulting from OCT scans. ICC will be calculated after all scans have been obtained.
ICC will be used to rank the HRFs. This statistical test is commonly used reliability index in test re-test studies.		 1 month
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