HydrocephalusNCT05397106
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
An observational study of Hydrocephalus and Hydrocephalus in Children, run by Integra LifeSciences Corporation at 9 sites in 4 countries.
Trial summary
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus)
- What is being tested?
- CODMAN CERTAS Plus Programmable Valve
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 24 Jan 2023to 24 Jan 2029
- 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: Consecutive patients of any age, gender, and ethnicity, with hydrocephalus. Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.
Who may be able to join
- Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
- Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
- Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
- For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.
Who cannot join
- Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
- Patient's planned shunt has distal drainage to the heart.
- Patient has ventriculitis, peritonitis or meningitis.
- Patient has sepsis.
- Patient has a history of poor wound healing.
- Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study.
Show all 11Show fewer
- Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
- Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
- Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
- Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
- Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany5 sites
Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf, 40225
Universitätsklinikum Essen
Essen
Freiburg University Hospital
Freiburg im Breisgau
Katharinenhospital - Neurochirurgische Klinik Stuttgart
Stuttgart
Belgium2 sites
University Hospital Leuven
Leuven
AZ Delta - Roeselare
Roeselare
About this study
Official title: Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Read the detailed description
The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.
This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.
Data collection for each patient will occur per standard of care.
However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.
Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension, Brain Tumor, Post-Traumatic Hydrocephalus
- Being tested
- CODMAN CERTAS Plus Programmable Valve
- Medical subject headings
- Hydrocephalus, Hydrocephalus, Normal Pressure, Pseudotumor Cerebri, Brain Neoplasms, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CODMAN CERTAS Plus Programmable ValveDevice
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
| Study group | Role | What they receive |
|---|---|---|
| CODMAN CERTAS Programmable Valves | CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve. Receives: Device: CODMAN CERTAS Plus Programmable Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
Device Success is defined as:
- Deployment with the correct valve positioning
- Original intended device in place, and
- No additional surgical or interventional procedures related to access or the device since completion of the original procedure.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start24 Jan 2023
- Primary completion24 Jan 2029 (estimated)
- Study completion24 Jan 2029 (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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherese Fralin, MSN, FNP, PhD, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397106
- Sponsor's protocol ID
- C-CERTAS-002
- Status last verified
- Feb 2026
- First submitted
- 25 May 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
- ClinicalTrials.gov ID
- NCT05397106
- Acronym / sponsor ID
- C-CERTAS-002
- Conditions
- Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension, Brain Tumor, Post-Traumatic Hydrocephalus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 Jan 2029 (estimated)
- Study completion
- 24 Jan 2029 (estimated)
- First posted
- 31 May 2022 (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.
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Detailed description
The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.
This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.
Data collection for each patient will occur per standard of care.
However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.
Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CODMAN CERTAS Programmable Valves | – | Device: CODMAN CERTAS Plus Programmable ValveCODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients of any age, gender, and ethnicity, with hydrocephalus. Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.
Key inclusion criteria (4 listed)
- Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
- Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
- Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
- For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.
Key exclusion criteria (11 listed)
- Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
- Patient's planned shunt has distal drainage to the heart.
- Patient has ventriculitis, peritonitis or meningitis.
- Patient has sepsis.
- Patient has a history of poor wound healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CODMAN CERTAS Plus Programmable ValvePatients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label. | Device | CODMAN CERTAS Programmable Valves |
Primary outcome
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
Time frame: 30 Days
Device Success is defined as: 1. Deployment with the correct valve positioning 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.
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 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sherese Fralin, MSN, FNP, PhD study director
Integra LifeSciences
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and Hydrocephalus in Children, run by Integra LifeSciences Corporation at 9 sites in 4 countries.
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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Belgium, Spain, Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment (time frame: 30 Days). 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 Feb 2026.