Follow-up on patients with CODMAN CERTAS Plus Programmable Valves

Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve

This study is tracking patients who have received the CODMAN CERTAS Plus Programmable Valve to see how well it works in managing their cerebrospinal fluid over three years.

Quick facts

• Study type: Observational
• Enrollment: 158 (estimated)
• Sex: All
• Sponsor: Integra LifeSciences Corporation (Industry-sponsored)
• Locations: 9 sites (Leuven and 8 other locations)
• Trial ID: NCT05397106 on ClinicalTrials.gov

What this trial studies

This observational study collects data on patients who have received the CODMAN CERTAS Plus Programmable Valve, an implantable device used to manage cerebrospinal fluid in conditions like hydrocephalus. The study aims to gather and analyze patient data from the date of implantation through three years post-surgery, with follow-up assessments at specified intervals. The valve's performance settings can be adjusted noninvasively after implantation, allowing for tailored treatment. Data collection will adhere to standard care protocols to ensure comprehensive monitoring of patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients of any age who are undergoing or have undergone surgery involving the CODMAN CERTAS Plus Programmable Valve.

Not a fit: Patients who are having the valve implanted as a revision procedure or have certain infections or complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the long-term effectiveness and safety of the CODMAN CERTAS Plus Programmable Valve in managing hydrocephalus and related conditions.

How similar studies have performed: While this study focuses on post-market follow-up, similar observational studies have shown success in monitoring implantable devices, indicating potential for valuable insights.

Eligibility criteria

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.

Where this trial is running

Leuven and 8 other locations

• University Hospital Leuven — Leuven, Belgium (Recruiting)
• AZ Delta - Roeselare — Roeselare, Belgium (Recruiting)
• Klinikum Dortmund Wirbelsäulenchirurgie — Dortmund, Germany (Recruiting)
• Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf — Düsseldorf, Germany (Recruiting)
• Universitätsklinikum Essen — Essen, Germany (Recruiting)
• Freiburg University Hospital — Freiburg, Germany (Recruiting)
• Katharinenhospital - Neurochirurgische Klinik Stuttgart — Stuttgart, Germany (Recruiting)
• Hospital12 de Octubre — Madrid, Spain (Not_yet_recruiting)
• Canton Hospital St. Gallen — St. Gallen, Switzerland (Recruiting)

Study contacts

• Study coordinator: Maria Salmon-Sargeant

Conditions Hydrocephalus; Hydrocephalus in Children; NPH; IIH - Idiopathic Intracranial Hypertension; Brain Tumor; Post-Traumatic Hydrocephalus; Hemorrhagic Stroke