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

Last updated: January 23, 2026
Sponsor: Sophysa
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04746625
PCLI 470-01
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient implanted with the Polaris® 24 adjustable valve system for the followingreasons:

  • 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, asper local regulations

Exclusion

Exclusion Criteria:

  • Confirmed or suspected infections along the length of the shunt (meningitis,ventriculitis, peritonitis, septicemia or bacteremia) or any infection present inany part of the body

  • Patient on anticoagulant therapy, or presenting with bleeding diathesis, or withhaemorrhagic CSF, as the presence of blood in the system could lead to anobstruction in the system

  • Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or othermalformations of the cardio-pulmonary system

Study Design

Total Participants: 126
Study Start date:
June 04, 2021
Estimated Completion Date:
June 30, 2033

Study 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.

Connect with a study center

  • La Timone Children's Hospital

    Marseille, 13385
    France

    Site Not Available

  • La Timone Children's Hospital

    Marseille 2995469, 13385
    France

    Active - Recruiting

  • La Pitié Salpétrière Hospital

    Paris, 75013
    France

    Site Not Available

  • La Pitié Salpétrière Hospital

    Paris 2988507, 75013
    France

    Active - Recruiting

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