Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03639870
Status:
UNKNOWN
Last Update Posted:
2021-04-23
First Post:
2018-08-17
Brief Title:
Investigation of the Glaukos Trabecular Micro-Bypass System Model iS3 in Subjects With Refractory Glaucoma
Sponsor:
Glaukos Corporation
Organization:
Glaukos Corporation
Study Overview
Official Title:
A Prospective Multicenter Clinical Investigation of the Glaukos Trabecular Micro-Bypass System Model iS3 in Subjects With Refractory Glaucoma
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Prospective multi-center single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos Trabecular Micro-Bypass System Model iS3 three stents per study eye in subjects with refractory glaucoma
Detailed Description:
This is a prospective multi-center single arm open-label clinical trial of the iS3 system Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively
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?:
None
Is an FDA AA801 Violation?:
None