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Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment — SAPPHYRE  

Hydrocephalus Clinical Trial

Official title:
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04746625
Study type Observational [Patient Registry]
Source Sophysa
Contact Hanta Ranaivoson, Msc
Phone +33 1 69 35 10 55
Email hranaivoson@sophysa.fr
Status Recruiting
Phase
Start date June 4, 2021
Completion date June 2028
View Details
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