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CLAiR Pivotal Study

NCT06808334 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 942

Last updated 2025-03-25

No results posted yet for this study

Summary

This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.

Conditions

  • No Condition

Interventions

OTHER

CLAIR

Subject will have retinal images obtained and uploaded to CLAiR Software. Subjects are not directly in contact with CLAiR software. There is no medical intervention.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Toku Eyes Ltd

    lead INDUSTRY

Principal Investigators

  • Michael McConnell, MD · Toku Inc.

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2025-06-01
Completion
2025-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06808334 on ClinicalTrials.gov