Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT02272569
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2014-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STARflo European Safety and Efficacy Study
Sponsor:
iSTAR Medical
Organization:
Study Overview
Official Title:
A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.
Detailed Description:
This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant.
Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.
When eligibility has been established using the in/exclusion criteria, surgery will be scheduled.
Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.
Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.
When eligibility has been established using the in/exclusion criteria, surgery will be scheduled.
Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following 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?: