Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467903
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-10
Brief Title:
Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners Using SW as Medical Device
Sponsor:
Bonmedix Holding as
Organization:
Bonmedix Holding as
Study Overview
Official Title:
A Prospective Comparative Multicenter Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners Using the SW as Medical Device and the SW as MD Comparator When Evaluating the Patients Retinal Image
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Retina
Brief Summary:
A prospective comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners using AI medical device
Detailed Description:
A prospective comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners using the SWaMD medical device and the SWaMD comparator when evaluating the patients retinal image
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| sukls1179452024 | OTHER | None | None |