Clinical trial NCT04746625: Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Official title: Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus
Keywords: Hydrocephalus
Adjustable valve
Polaris 24
Cerebrospinal fluid
Lead sponsor: Sophysa
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, children and neonates, regardless of gender with hydrocephalus.

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.

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

Primary outcomes:
measure: Device-related SAE / complications
timeFrame: 1 year
measure: Valve replacement
timeFrame: 1 year
Secondary outcomes:
measure: All adverse events / complications
timeFrame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
measure: Valve replacement
timeFrame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
measure: Implant procedure success
timeFrame: 0 day (post-procedure)
measure: Change of clinical status scores
timeFrame: One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
measure: Evolution of Clinical symptoms
timeFrame: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
measure: MRI stability
timeFrame: One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
measure: Valve pressure adjustment
timeFrame: (if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
Other outcomes:
Locations:
city: Marseille
country: France
facility: La Timone Children's Hospital
city: Paris
country: France
facility: La Pitié Salpétrière Hospital
Study officials:
affiliation: La Timone Children's Hospital - Paediatrics Neurosurgery Department
name: Didier Scavarda, Prof
role: PRINCIPAL_INVESTIGATOR
References: