NCT04746625 Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
| NCT ID | NCT04746625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sophysa |
| Condition | Hydrocephalus |
| Study Type | OBSERVATIONAL |
| Enrollment | 126 participants |
| Start Date | 2021-06-04 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 126 participants in total. It began in 2021-06-04 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Didier Scavarda, Prof
PRINCIPAL INVESTIGATOR
La Timone Children's Hospital - Paediatrics Neurosurgery Department
Frequently Asked Questions
Who can join the NCT04746625 clinical trial?
This trial is open to participants of all sexes, studying Hydrocephalus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04746625 currently recruiting?
Yes, NCT04746625 is actively recruiting participants. Contact the research team at oamiotte@sophysa.fr for enrollment information.
Where is the NCT04746625 trial being conducted?
This trial is being conducted at Marseille, France, Paris, France.
Who is sponsoring the NCT04746625 clinical trial?
NCT04746625 is sponsored by Sophysa. The principal investigator is Didier Scavarda, Prof at La Timone Children's Hospital - Paediatrics Neurosurgery Department. The trial plans to enroll 126 participants.