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

Hydrocephalus Clinical Trial

— SAPPHYRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746625
• Other study ID #: PCLI 470-01
• Status: Recruiting
• Start date: June 4, 2021
• Est. completion date: June 2028

Study information

• Verified date: June 2021
• Source: Sophysa
• Contact: Hanta Ranaivoson, Msc
• Phone: +33 1 69 35 10 55
• Email: hranaivoson[@]sophysa.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: June 2028
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Locations

Country	Name	City	State
France	La Timone Children's Hospital	Marseille
France	La Pitié Salpétrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sophysa

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related SAE / complications	Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications	1 year
Primary	Valve replacement	Primary performance outcome will be assessed by the incidence of valve replacements	1 year
Secondary	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
Secondary	Valve replacement	Incidence of valve replacements	Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Secondary	Implant procedure success	Implant procedure success, defined as no immediate re-intervention post-procedure	0 day (post-procedure)
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Sponsor's website