Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

NCT05397106 | Active Not Recruiting

• 1 other identifier: C-CERTAS-002
• Study Type: observational
• Target: 160
• Locations: 4 countries
• Sites: 9

Brief Summary

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

Conditions

Hydrocephalus; Hydrocephalus in Children; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension; Brain Tumor; Post-Traumatic Hydrocephalus; Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment

  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.

  30 Days

Other Outcomes (3)

• Incidence of Valve Replacement

  12, 24 and 36 Months

• Adverse Events

  12, 24 and 36 Months

• Number of encounters with inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves

  12, 24 and 36 Months

Study Arms (1)

CODMAN CERTAS Programmable Valves

CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Device: CODMAN CERTAS Plus Programmable Valve

Interventions

CODMAN CERTAS Plus Programmable Valve DEVICE

Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

CODMAN CERTAS Programmable Valves

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
• Patient's planned shunt has distal drainage to the heart.
• Patient has ventriculitis, peritonitis or meningitis.
• Patient has sepsis.
• 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.
• 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 otherwise determined by the Investigator to be medically unsuitable for participation in this study.
• Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
• Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (9)

University Hospital Leuven

Leuven, Belgium

Location

AZ Delta - Roeselare

Roeselare, Belgium

Location

Klinikum Dortmund Wirbelsäulenchirurgie

Dortmund, Germany

Location

Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Freiburg University Hospital

Freiburg im Breisgau, Germany

Location

Katharinenhospital - Neurochirurgische Klinik Stuttgart

Stuttgart, Germany

Location

Hospital12 de Octubre

Madrid, Spain

Location

Canton Hospital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Hydrocephalus; Hydrocephalus, Normal Pressure; Pseudotumor Cerebri; Brain Neoplasms; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sherese Fralin, MSN, FNP, PhD

  Integra LifeSciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: January 24, 2023
• Primary Completion (Estimated): January 24, 2029
• Study Completion (Estimated): January 24, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); ES (1); BE (2); DE (5)