Trials / Recruiting
RecruitingNCT04746625
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 126 (estimated)
- Sponsor
- Sophysa · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.
Detailed description
The SAPPHYRE study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. The study objective is to evaluate the safety and performance of Sophysa's CE marked Polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. It is expected to recruit 126 patients in two-year. Patients will be followed-up up to 5 years post-procedure.
Conditions
Timeline
- Start date
- 2021-06-04
- Primary completion
- 2029-06-01
- Completion
- 2033-06-01
- First posted
- 2021-02-10
- Last updated
- 2026-01-27
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04746625. Inclusion in this directory is not an endorsement.