RecruitingNCT04746625
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Sponsor
Sophysa
Enrollment
126 participants
Start Date
Jun 4, 2021
Study Type
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria3
- 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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Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04746625
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