Evaluating the Polaris® 24 Valve System for Hydrocephalus Treatment
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
This study is testing a new adjustable valve system for treating hydrocephalus to see how safe and effective it is for patients who have received it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Sex | All |
| Sponsor | Sophysa Industry-sponsored |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT04746625 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients who have received the Polaris® 24 adjustable valve system for hydrocephalus management.
Not a fit: Patients with confirmed infections along the shunt or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with hydrocephalus.
How similar studies have performed: While this approach is based on existing valve systems, the specific evaluation of the Polaris® 24 is novel and not extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Marseille and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.