Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-26 @ 11:03 AM
Study NCT ID:
NCT04100135
Status:
TERMINATED
Last Update Posted:
2024-12-18
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dissatisfactory enrollment rate with no safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIEF
Brief Summary:
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: