Status:
RECRUITING
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Lead Sponsor:
Sophysa
Conditions:
Hydrocephalus
Eligibility:
All Genders
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 o...
Detailed Description
The SAPPHYRE study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. The study objective is to evaluate the safety and performa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04746625
Start Date
June 4 2021
End Date
June 1 2028
Last Update
June 9 2021
Active Locations (2)
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1
La Timone Children's Hospital
Marseille, France, 13385
2
La Pitié Salpétrière Hospital
Paris, France, 75013