Clinical Trial

Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus

Name: Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus — clinical trial record (NCT07378956)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SAFE-DM

Recruiting

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Summary

The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.

Protocol Amendment History 1 change

critical Recruitment opened 2026-04-14

Trial Details

NCT Number	NCT07378956
Lead Sponsor	VUNO Inc.
Conditions	Diabetic Retinopathy (DR), Diabete Mellitus, Fundus Photography
Enrollment	340 participants
Start Date	2026-04-07
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-13