Actively Recruiting
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Led by Sophysa · Updated on 2026-01-27
126
Participants Needed
2
Research Sites
625 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient implanted with the Polaris4 24 adjustable valve system as a first implant, a replacement valve, or after endoscopic ventriculostomy failure
- Patient has given informed consent according to local regulations
You will not qualify if you...
- Confirmed or suspected infections along the shunt or elsewhere in the body such as meningitis, ventriculitis, peritonitis, septicemia, or bacteremia
- Patient on anticoagulant therapy, has bleeding diathesis, or hemorrhagic cerebrospinal fluid
- Ventriculo-atrial shunts in patients with congenital heart defects or other cardio-pulmonary malformations
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
La Timone Children's Hospital
Marseille, France, 13385
Actively Recruiting
2
La Pitié Salpétrière Hospital
Paris, France, 75013
Actively Recruiting
Research Team
O
Océane Amiotte, Engineering Degree
CONTACT
H
Huong Tra LE, Msc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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