Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04409808
Status:
TERMINATED
Last Update Posted:
2022-11-16
First Post:
2020-05-05
Brief Title:
IRIS Alfa Clinical Trial A Monocentric Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
IRIS Alfa Clinical Trial A Safety Study of a Prototype of a New Vitrectomy Device
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
because a device deficiency that occured in the Iris vitrectomy system Alfa version
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRIS
Brief Summary:
To perform a safety study on the prototype IRIS vitrectomy device
Detailed Description:
to determine the safety and effectiveness of the device
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