Trials / Not Yet Recruiting
Not Yet RecruitingNCT07022249
Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intrasaccular Embolization Device | This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. |
Timeline
- Start date
- 2025-06-01
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2025-06-15
- Last updated
- 2025-06-15
Source: ClinicalTrials.gov record NCT07022249. Inclusion in this directory is not an endorsement.