Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment (SAPPHYRE)

Sophysa

Status: Enrolling

Conditions: Hydrocephalus

Study type: Observational

Funder types: Industry

Identifiers

NCT04746625

PCLI 470-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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