Status: Recruiting
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.
Participants needed: 126
Trial details
Biological sex: AllType: ObservationalSponsor: SophysaUpdated: Jan 27, 2026Locations: 2Duration: 5 Years
Eligibility criteria
Primo implant of a valve shunt-based derivation system, or as a [+3]
Confirmed or suspected infections along the length of the shunt (meningitis, ven... [+2]