NCT07378956 Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
| NCT ID | NCT07378956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VUNO Inc. |
| Condition | Diabetic Retinopathy (DR) |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2026-04-07 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adults aged 19 years or older. * A documented diagnosis of type 2 diabetes mellitus. * Ability to communicate adequately and provide written informed consent for participation in the study. Exclusion Criteria: * A prior diagnosis of diabetic retinopathy at the time of screening. * A history of ophthalmic surgery within 6 months prior to the screening date. * A diagnosis of type 1 diabetes mellitus. * Pregnancy at the time of screening. * Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07378956 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Diabetic Retinopathy (DR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07378956 currently recruiting?
Yes, NCT07378956 is actively recruiting participants. Contact the research team at heejun.park@vuno.co for enrollment information.
Where is the NCT07378956 trial being conducted?
This trial is being conducted at Incheon, South Korea.
Who is sponsoring the NCT07378956 clinical trial?
NCT07378956 is sponsored by VUNO Inc.. The trial plans to enroll 340 participants.