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NCT04746625

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

Sophysa·ClinicalTrials.govRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hydrocephalus
Study type
Observational
Sponsor & location
Primary sponsor
Sophysa
Location
Marseille,Paris, France
Timeline & enrollment
Phase
N/A
Start date
Jun 04, 2021
End date
Jun 01, 2028
Enrollment
126 participants
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
HydrocephalusHydrocephalus, unspecifiedOther hydrocephalusCongenital hydrocephalusObstructive hydrocephalus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04746625
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.