Trials / Recruiting
RecruitingNCT06498960
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- CereVasc Inc · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
Detailed description
The STRIDE study is a prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CereVasc eShunt System | The eShunt System consists of the following components: * eShunt Implant * eShunt Delivery Catheter and Transfer Tool * eShunt Anchor |
| DEVICE | VP Shunt | Control arm - VP shunt |
Timeline
- Start date
- 2024-11-26
- Primary completion
- 2026-12-01
- Completion
- 2031-06-01
- First posted
- 2024-07-12
- Last updated
- 2026-02-23
Locations
30 sites across 3 countries: United States, Argentina, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06498960. Inclusion in this directory is not an endorsement.