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

Recruitingn/aAges any - anyAllSophysa
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

2 sites
La Timone Children's Hospital
Marseille, France
La Pitié Salpétrière Hospital
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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