Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-19
Brief Title:
An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol
Sponsor:
New World Medical Inc
Organization:
New World Medical Inc
Study Overview
Official Title:
An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE SURGICAL SYSTEM
Detailed Description:
A Retrospective nonrandomized open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol
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