Brain valve registry checks safety in 160 patients
NCT ID NCT05397106
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 160 people who have or will get a CODMAN CERTAS Plus valve, a device implanted in the brain to drain extra fluid. The main goal is to see if the valve is placed correctly and works without problems 30 days after surgery. Participants include children and adults with conditions like hydrocephalus, brain tumors, or stroke.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CODMAN CERTAS Plus Programmable Valve (a surgically implanted device that helps drain excess fluid from the brain)
- What this could lead to
- If successful, this study will confirm that the valve is safe and works as intended for people with hydrocephalus.
- What could go wrong
- This is an observational registry, not a test of a new treatment. It only checks short-term device placement, not long-term benefits or risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
160 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable. 2. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves. 3. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements. 4. 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. Exclusion Criteria: 1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure. 2. Patient's planned shunt has distal drainage to the heart. 3. Patient has ventriculitis, peritonitis or meningitis. 4. Patient has sepsis. 5. Patient has a history of poor wound healing. 6. 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. 7. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant. 8. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study. 9. Patient is currently enrolled in another drug or device trial or has been previously entered in this trial. 10. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator. 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Delta - Roeselare
Roeselare, Belgium
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Canton Hospital St. Gallen
Sankt Gallen, Switzerland
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Freiburg University Hospital
Freiburg im Breisgau, Germany
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Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Düsseldorf, 40225, Germany
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Hospital12 de Octubre
Madrid, Spain
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Katharinenhospital - Neurochirurgische Klinik Stuttgart
Stuttgart, Germany
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Klinikum Dortmund Wirbelsäulenchirurgie
Dortmund, Germany
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University Hospital Leuven
Leuven, Belgium
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Universitätsklinikum Essen
Essen, Germany
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Other studies related to the condition(s) this trial covers.
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- Zapping the brain to restore lost vision
- Wireless skin sensor aims to detect silent shunt failures
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