Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Recruiting

• Conditions: Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension; Brain Tumor; Hydrocephalus in Children; Hemorrhagic Stroke; Post-Traumatic Hydrocephalus
• Interventions: Device: CODMAN CERTAS Plus Programmable Valve

• Registration Number: NCT05397106
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

Detailed Description

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.

This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.

Data collection for each patient will occur per standard of care.

However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.

Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2023-01-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2027-08-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CODMAN CERTAS Programmable Valves	CODMAN CERTAS Plus Programmable Valve	CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Primary Outcome Measures

Name	Time	Method
Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment	30 Days	Device Success is defined as: 1. Deployment with the correct valve positioning; 2. Original intended device in place, and; 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.

Trial Locations

Locations (9)

University Hospital Leuven; 🇧🇪 Leuven, Belgium

AZ Delta - Roeselare; 🇧🇪 Roeselare, Belgium

Klinikum Dortmund Wirbelsäulenchirurgie; 🇩🇪 Dortmund, Germany

Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Freiburg University Hospital; 🇩🇪 Freiburg, Germany

Katharinenhospital - Neurochirurgische Klinik Stuttgart; 🇩🇪 Stuttgart, Germany

Hospital12 de Octubre; 🇪🇸 Madrid, Spain

Canton Hospital St. Gallen; 🇨🇭 St. Gallen, Switzerland