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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
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

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
AZ Delta Roeselare
Coordinator of this site? Confirm its status
RoeselareBelgiumUnknown status
Canton Hospital St. Gallen
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
Klinikum Dortmund Wirbelsäulenchirurgie
Coordinator of this site? Confirm its status
DortmundGermanyUnknown status
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
Universitätsklinikum Essen
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Freiburg University Hospital
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyUnknown status
Katharinenhospital - Neurochirurgische Klinik Stuttgart
Coordinator of this site? Confirm its status
StuttgartGermanyUnknown status
Hospital12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.