Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
La Timone Children's Hospital
NOT_YET_RECRUITING
Marseille
La Pitié Salpétrière Hospital
RECRUITING
Paris
Contact Information
Primary
Hanta Ranaivoson, Msc
hranaivoson@sophysa.fr
+33 1 69 35 10 55
Backup
Vi-Phong Huynh, Msc
vhuynh@sophysa.com
+33 1 69 35 10 50
Time Frame
Start Date: 2021-06-04
Estimated Completion Date: 2028-06
Participants
Target number of participants: 126
Related Therapeutic Areas
Sponsors
Leads: Sophysa