Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05229094
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2021-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EVA Nexus Vitrectomy Device Field Observation Study
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
EVA Nexus Field Observation Study. A Monocentric, Academic Field Observation Study of a Prototype of a New CE-labeled Vitrectomy Device Developed by DORC BV (The Netherlands).
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
determine the safety and effectiveness of the device.
Detailed Description:
To perform a field observation study using the newly developed EVA Nexus vitrectomy device.
Patients that are scheduled for intra-ocular surgery regardless of the indication:
* Vitrectomy surgery
* Cataract surgery
* Vitrectomy combined with cataract surgery
Patients that are scheduled for intra-ocular surgery regardless of the indication:
* Vitrectomy surgery
* Cataract surgery
* Vitrectomy combined with cataract surgery
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?: