Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Brain valve registry checks safety in 160 patients

NCT ID NCT05397106

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jan 2023

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Brain tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • AZ Delta - Roeselare

    Roeselare, Belgium

  • Canton Hospital St. Gallen

    Sankt Gallen, Switzerland

  • Freiburg University Hospital

    Freiburg im Breisgau, Germany

  • Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf

    Düsseldorf, 40225, Germany

  • Hospital12 de Octubre

    Madrid, Spain

  • Katharinenhospital - Neurochirurgische Klinik Stuttgart

    Stuttgart, Germany

  • Klinikum Dortmund Wirbelsäulenchirurgie

    Dortmund, Germany

  • University Hospital Leuven

    Leuven, Belgium

  • Universitätsklinikum Essen

    Essen, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.