Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment - Trial NCT04746625
Access comprehensive clinical trial information for NCT04746625 through Pure Global AI's free database. This phase not specified trial is sponsored by Sophysa and is currently Recruiting. The study focuses on Hydrocephalus. Target enrollment is 126 participants.
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Study Focus
Observational
Sponsor & Location
Sophysa
Timeline & Enrollment
N/A
Jun 04, 2021
Jun 01, 2028
Primary Outcome
Device-related SAE / complications,Valve replacement
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04746625
Non-Device Trial