HydrocephalusSAPPHYRENCT04746625
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
An observational study of Hydrocephalus, run by Sophysa at 2 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- How many people
- 126 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jun 2021to Jun 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults, children and neonates, regardless of gender with hydrocephalus.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
La Timone Children's Hospital
Marseille, 13385
Didier Scavarda, Prof
- Recruiting
La Pitié Salpétrière Hospital
Paris, 75013
Bertrand Mathon, MD
About this study
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.
Read the 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.
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus, Adjustable valve, Polaris 24, Cerebrospinal fluid
- Medical subject headings
- Hydrocephalus
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related SAE / complications
Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
Measured: 1 year
Valve replacement
Primary performance outcome will be assessed by the incidence of valve replacements
Measured: 1 year
Secondary outcomes (7)
All adverse events / complications
Long term safety will be assessed by the incidence of all adverse events/complications
Measured: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Valve replacement
Incidence of valve replacements
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: (if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start4 Jun 2021
- Primary completionJun 2029 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 126 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sophysa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Scavarda, Prof, Principal investigator, La Timone Children's Hospital - Paediatrics Neurosurgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746625
- Sponsor's protocol ID
- PCLI 470-01
- Acronym
- SAPPHYRE
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
- ClinicalTrials.gov ID
- NCT04746625
- Acronym / sponsor ID
- SAPPHYRE / PCLI 470-01
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus, Adjustable valve, Polaris 24, Cerebrospinal fluid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- SophysaIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, children and neonates, regardless of gender with hydrocephalus.
Key inclusion criteria (5 listed)
- Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:
- Patient having given his/her informed consent prior to inclusion in this study, as per local regulations
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device-related SAE / complications
Time frame: 1 year
Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
Valve replacement
Time frame: 1 year
Primary performance outcome will be assessed by the incidence of valve replacements
7 secondary outcomes
All adverse events / complications
Time frame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Valve replacement
Time frame: Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation
Implant procedure success
Time frame: 0 day (post-procedure)
Change of clinical status scores
Time frame: One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
Evolution of Clinical symptoms
Time frame: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
MRI stability
Time frame: One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation
Valve pressure adjustment
Time frame: (if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Didier Scavarda, Prof principal investigator
La Timone Children's Hospital - Paediatrics Neurosurgery Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Sophysa at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Océane Amiotte, Engineering Degree (+33 381885382, oamiotte@sophysa.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related SAE / complications (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.