Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
SAPPHYRE
1 other identifier
observational
126
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
June 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2033
January 27, 2026
January 1, 2026
8 years
February 2, 2021
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Device-related SAE / complications
Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
1 year
Valve replacement
Primary performance outcome will be assessed by the incidence of valve replacements
1 year
Secondary Outcomes (7)
All adverse events / complications
Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Valve replacement
Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Implant procedure success
0 day (post-procedure)
Change of clinical status scores
One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
Evolution of Clinical symptoms
One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
- +2 more secondary outcomes
Eligibility Criteria
Adults, children and neonates, regardless of gender with hydrocephalus.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sophysalead
Study Sites (2)
La Timone Children's Hospital
Marseille, 13385, France
La Pitié Salpétrière Hospital
Paris, 75013, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Scavarda, Prof
La Timone Children's Hospital - Paediatrics Neurosurgery Department
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 10, 2021
Study Start
June 4, 2021
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2033
Last Updated
January 27, 2026
Record last verified: 2026-01