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

Recruiting now

Conditions studied: Hydrocephalus

In brief

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.

Key facts

Study ID

NCT04746625

Run by

Sophysa

People needed

126

Starts

2021-06-04

Expected to finish

2033-06-01

Last updated by the study team

2026-01-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:
• Primo implant of a valve shunt-based derivation system, or as a
• Replacement of another valve -based shunt system, or
• Endoscopic ventriculostomy (EVT) failure
• Patient having given his/her informed consent prior to inclusion in this study, as per local regulations

You may not qualify if…

• Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body
• Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system
• Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system

Where it is running

• La Timone Children's Hospital — Marseille, France (enrolling)
• La Pitié Salpétrière Hospital — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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