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NCT Number: NCT04746625

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

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.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

La Timone Children's Hospital, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Device-related SAE / complications

    Time frame: 1 year

    Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications

  2. Valve replacement

    Time frame: 1 year

    Primary performance outcome will be assessed by the incidence of valve replacements

Secondary outcomes

  1. All adverse events / complications

    Time frame: 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

  2. Valve replacement

    Time frame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation

    Incidence of valve replacements

  3. Implant procedure success

    Time frame: 0 day (post-procedure)

    Implant procedure success, defined as no immediate re-intervention post-procedure

  4. Change of clinical status scores

    Time frame: 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)

  5. Evolution of Clinical symptoms

    Time frame: 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)

  6. MRI stability

    Time frame: 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

  7. 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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Huong Tra LE, Msc

CONTACT

[email protected]

+33 1 69 35 3500

Océane Amiotte, Engineering Degree

CONTACT

[email protected]

+33 381885382

Sponsors and collaborators

Lead sponsor

Sophysa

Industry

Registry information

Acronym: SAPPHYRE

Important dates

Study start
2021
Primary completion
2029
Study completion
2033
First posted
Feb 10, 2021
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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