Hydrocephalus
Conditions
Keywords
Hydrocephalus, Adjustable valve, Polaris 24, Cerebrospinal fluid
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.
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.
Interventions
None listed
Sponsors
Sophysa
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-related SAE / complications | 1 year | Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications |
| Valve replacement | 1 year | Primary performance outcome will be assessed by the incidence of valve replacements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All adverse events / complications | Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation | Long term safety will be assessed by the incidence of all adverse events/complications |
| Valve replacement | Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation | Incidence of valve replacements |
| Implant procedure success | 0 day (post-procedure) | Implant procedure success, defined as no immediate re-intervention post-procedure |
| Change of clinical status scores | One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation | Improvement of the following clinical status scores compared to baseline: the Modified Rankin Scale (for adults and children) and the Lansky Performance Scale (for children \< 16 years old only) |
| Evolution of Clinical symptoms | One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation | Clinical symptoms will be assessed according to a 4-grade scale (excellent, good, unchanged, worsened) |
| MRI stability | One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation | MRI (1.5Tesla or 3Tesla) stability of the pressure adjustment |
| Valve pressure adjustment | (if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation | If required by patient's condition, the physician will adjust the valve pressure with the adjustment kit provided with the Polaris 24 valve. Physician will evaluate the ease of reading and adjusting of the valve pressure (from easy to difficult) |
Countries
France
Contacts
CONTACTOcéane Amiotte, Engineering Degree
CONTACTHuong Tra LE, Msc
PRINCIPAL_INVESTIGATORDidier Scavarda, Prof
La Timone Children's Hospital - Paediatrics Neurosurgery Department
Outcome results
None listed