clinical trial · NCT04746625
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Sophysa·—·recruiting·n = 126
Hydrocephalus
brief 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.
started
Jun 4, 2021
primary completion
Jun 1, 2029
completion
Jun 1, 2033
last updated
Jan 27, 2026
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol