Polaris® 24 Valve System for Hydrocephalus Treatment
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
- Sex
- Any
- Study type
- Observational
- Participants needed
- 126 (estimated)
- Sponsor
- Sophysa · Industry
This trial is looking for patients with hydrocephalus who are being treated with the Polaris® 24 adjustable valve system. Participants will help evaluate how safe and effective this valve system is in managing their condition.
You may be able to join if
- I have hydrocephalus.
- I have been implanted with the Polaris® 24 adjustable valve system.
- I have had an initial implant of a valve shunt system.
- I am replacing another valve-based shunt system.
- I have experienced failure of endoscopic ventriculostomy.
- I have given my informed consent to participate.
You may not be able to join if
- I have confirmed or suspected infections related to the shunt.
- I am on anticoagulant therapy.
- I have bleeding issues or have bleeding in my cerebrospinal fluid.
- I have ventriculo-atrial shunts and congenital heart problems.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your EligibilityThe 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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