NCT05397106Active, not recruiting
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 160 (actual)
- First submitted
- 25 May 2022
- Start date
- 24 Jan 2023
- Primary completion date
- 24 Jan 2029
- Lead sponsor
- Integra LifeSciences Corporation
- Diseases
- Stroke, High blood pressure, Childhood cancers
- NCT number
- NCT05397106
What you commit to
- Study type: Observational
- Participants enrolled: 160
- From 24 Jan 2023 to the primary completion date, 24 Jan 2029
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 currently enrolled in another drug or device trial or has been previously entered in this trial.
- 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.
Other illness
- Patient's planned shunt has distal drainage to the heart.
- 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.
Other
- Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
- Patient has ventriculitis, peritonitis or meningitis.
- Patient has sepsis.
- Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
- Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| AZ Delta Roeselare Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| Canton Hospital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Klinikum Dortmund Wirbelsäulenchirurgie Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Freiburg University Hospital Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| Katharinenhospital - Neurochirurgische Klinik Stuttgart Coordinator of this site? Confirm its status | Stuttgart | Germany | Unknown status |
| Hospital12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.