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

Key facts

Who runs it
Sophysa
Where
France2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
126 people, planned
Started
4 Jun 2021
Expected to end
Jun 2033
Type of study
Observational
Record updated
27 January 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
27 January 2026