Trials / Recruiting
RecruitingNCT07378956
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- Sponsor
- VUNO Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary objective of this study is to compare the true referral rate between patients with VUNO Med®-Fundus AI™-assisted screening (intervention group) and those receiving usual clinical care without AI assistance (control group) among patients with diabetes mellitus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VUNO Med®-Fundus AI™ | VUNO Med®-Fundus AI™ is an artificial intelligence-based fundus image detection and diagnostic support software. The software automatically identifies abnormal retinal findings and provides information on the type and location of detected abnormalities to aid clinical decision-making. |
Timeline
- Start date
- 2026-04-07
- Primary completion
- 2027-08-31
- Completion
- 2027-08-31
- First posted
- 2026-01-30
- Last updated
- 2026-04-13
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT07378956. Inclusion in this directory is not an endorsement.