Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSophysa
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults, children and neonates, regardless of gender with hydrocephalus.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Device-related SAE / complications
Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
Time frame
1 year2
Valve replacement
Primary performance outcome will be assessed by the incidence of valve replacements
Time frame
1 yearSecondary outcomes
1
All adverse events / complications
Long term safety will be assessed by the incidence of all adverse events/complications
Time frame
Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation2
Valve replacement
Incidence of valve replacements
Time frame
Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation3
Implant procedure success
Implant procedure success, defined as no immediate re-intervention post-procedure
Time frame
0 day (post-procedure)4
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)
Time frame
One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation Source ClinicalTrials.gov