Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808699
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-03-29
Brief Title:
Camera Qualification Study
Sponsor:
Digital Diagnostics Inc
Organization:
Digital Diagnostics Inc
Study Overview
Official Title:
Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR
Detailed Description:
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None