Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment (SAPPHYRE)

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.

Study Overview

• Status: Recruiting
• Conditions: Hydrocephalus

Detailed Description

The SAPPHYRE study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. The study objective is to evaluate the safety and performance of Sophysa's CE marked Polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. It is expected to recruit 126 patients in two-year. Patients will be followed-up up to 5 years post-procedure.

• Study Type: Observational
• Enrollment (Anticipated): 126

Contacts and Locations

• Study Contact: Name: Hanta Ranaivoson, Msc; Phone Number: +33 1 69 35 10 55; Email: hranaivoson@sophysa.fr
• Study Contact Backup: Name: Vi-Phong Huynh, Msc; Phone Number: +33 1 69 35 10 50; Email: vhuynh@sophysa.com

Study Locations

• France
  • Marseille, France, 13385
    • Not yet recruiting
    • La Timone Children's Hospital
    • Contact: Didier Scavarda, Prof
  • Paris, France, 75013
    • Recruiting
    • La Pitié Salpêtrière Hospital
    • Contact: Bertrand Mathon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults, children and neonates, regardless of gender with hydrocephalus.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All adverse events / complications	Long term safety will be assessed by the incidence of all adverse events/complications	Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Valve replacement	Incidence of valve replacements	Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Implant procedure success	Implant procedure success, defined as no immediate re-intervention post-procedure	0 day (post-procedure)
Change of clinical status scores	Improvement of the following clinical status scores compared to baseline: the Modified Rankin Scale (for adults and children) and the Lansky Performance Scale (for children < 16 years old only)	One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
Evolution of Clinical symptoms	Clinical symptoms will be assessed according to a 4-grade scale (excellent, good, unchanged, worsened)	One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
MRI stability	MRI (1.5Tesla or 3Tesla) stability of the pressure adjustment	One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
Valve pressure adjustment	If required by patient's condition, the physician will adjust the valve pressure with the adjustment kit provided with the Polaris 24 valve. Physician will evaluate the ease of reading and adjusting of the valve pressure (from easy to difficult)	(if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation

Collaborators and Investigators

• Sponsor: Sophysa
• Investigators: Principal Investigator: Didier Scavarda, Prof, La Timone Children's Hospital - Paediatrics Neurosurgery Department

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2021
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): June 1, 2028

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (ACTUAL): February 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Cerebrospinal fluid; Hydrocephalus; Adjustable valve; Polaris 24
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: PCLI 470-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No