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

Sponsor

Sophysa (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04746625

Collaborator

(none)

126

Enrollment

Locations

83.9

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

126 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jun 4, 2021

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2028

Outcome Measures

Primary Outcome Measures

Device-related SAE / complications [1 year]
Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
Valve replacement [1 year]
Primary performance outcome will be assessed by the incidence of valve replacements

Secondary Outcome Measures

All adverse events / complications [Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation]
Long term safety will be assessed by the incidence of all adverse events/complications
Valve replacement [Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation]
Incidence of valve replacements
Implant procedure success [0 day (post-procedure)]
Implant procedure success, defined as no immediate re-intervention post-procedure
Change of clinical status scores [One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation]
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)
Evolution of Clinical symptoms [One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation]
Clinical symptoms will be assessed according to a 4-grade scale (excellent, good, unchanged, worsened)
MRI stability [One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation]
MRI (1.5Tesla or 3Tesla) stability of the pressure adjustment
Valve pressure adjustment [(if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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