Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 12:17 PM
Study NCT ID:
NCT06158750
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
Sponsor:
Shanghai Wallaby Medical Technologies Co.,Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
Status:
RECRUITING
Status Verified Date:
2023-11
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 assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Detailed Description:
Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms.
Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study.
Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device .
Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study.
Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device .
Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
Study Oversight
Has Oversight DMC:
None
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?: