Safety and Performance of the Polaris 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

  • STATUS
    Recruiting
  • End date
    Jun 20, 2028
  • participants needed
    126
  • sponsor
    Sophysa
Updated on 20 June 2021

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.

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.

Details
Condition Hydrocephalus
Clinical Study IdentifierNCT04746625
SponsorSophysa
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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