Evaluating the Polaris® 24 Valve System for Hydrocephalus Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SAPPHYRE study is an ambispective clinical follow-up that aims to assess the safety and performance of the Polaris® 24 adjustable valve system in treating hydrocephalus. This multicenter study will involve 126 patients who have been implanted with the valve, either as a first-time procedure or as a replacement for another system. Patients will be monitored for up to five years post-implantation to gather data on outcomes and any adverse events.

Why it matters

Who can join: the full rules

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

Where it's running

• La Timone Children's Hospital
  Marseille, France Recruiting
• La Pitié Salpétrière Hospital
  Paris, France Recruiting

Study contacts

• Principal investigator: Didier Scavarda, Prof — La Timone Children's Hospital - Paediatrics Neurosurgery Department
• Study coordinator: Océane Amiotte, Engineering Degree
• Email: oamiotte@sophysa.fr
• Phone: +33 381885382

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wearable sensor to detect CSF flow in shunt tubing

  This will test a small, wireless skin sensor to see if it can detect cerebrospinal fluid (CSF) flow through implanted shunts in children and adults with stable hydrocephalus.

  Recruiting Rhaeos, Inc. · Peoria, Illinois · NCT07478926

• CSF lactate and other biomarkers in patients with an external ventricular drain after acute brain injury

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• See if a wireless thermal device can measure CSF shunt flow during daily activities and sleep

  A wireless thermal device is being tested to see if it can non-invasively monitor CSF shunt flow in people with hydrocephalus during everyday activities and sleep.

  Recruiting at 2 sites Rhaeos, Inc. · Chicago, Illinois and 1 other locations · NCT07050628

• Evaluating a device for measuring cerebrospinal fluid flow and headaches

  This study is testing a new device that measures the flow of cerebrospinal fluid in people with hydrocephalus to see if it can help understand their headaches better.

  Recruiting Rhaeos, Inc. · Chicago, Illinois · NCT06996600

• Understanding brain and heart injuries after bleeding in the brain

  This study looks at how bleeding in the brain affects both the brain and the heart in adults to better understand the connection between these injuries.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT06906432

• Light therapy for severe neonatal brain bleeding

  This study is testing if a special light therapy can help newborns with severe brain bleeding feel better and develop normally over time.

  Recruiting at 2 sites Rutgers, The State University of New Jersey · Newark, New Jersey and 1 other locations · NCT06797219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.