Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:54 AM
Study NCT ID:
NCT07378956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes
Sponsor:
VUNO Inc.
Organization:
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE-DM
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: