Trials / Recruiting
RecruitingNCT06158750
To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Shanghai Wallaby Medical Technologies Co.,Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | p64/p48 MW HPC Flow Modulation Device | Endovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms |
Timeline
- Start date
- 2023-11-17
- Primary completion
- 2026-02-28
- Completion
- 2026-06-30
- First posted
- 2023-12-06
- Last updated
- 2024-06-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06158750. Inclusion in this directory is not an endorsement.