Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hydrocephalus. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 performance of Sophysa's CE marked Polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. It is expected to recruit 126 patients in two-year. Patients will be followed-up up to 5 years post-procedure.
Primary outcome measures
- Device-related SAE / complications [Time frame: 1 year]
- Valve replacement [Time frame: 1 year]
Secondary outcome measures (7)
- All adverse events / complications [Time frame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation]
- Valve replacement [Time frame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation]
- Implant procedure success [Time frame: 0 day (post-procedure)]
- Change of clinical status scores [Time frame: One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation]
- Evolution of Clinical symptoms [Time frame: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation]
- MRI stability [Time frame: One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation]
- Valve pressure adjustment [Time frame: (if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- La Timone Children's Hospital — Marseille
- La Pitié Salpétrière Hospital — Paris
Identifiers
NCT: NCT04746625 · PCLI 470-01