Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 158

Contacts and Locations

• Study Contact: Name: Maria Salmon-Sargeant; Phone Number: 339-206-2979; Email: maria.salmonsargeant@integralife.com
• Study Contact Backup: Name: Andrew Tummon; Phone Number: 1-609-936-5490; Email: Andrew.Tummon@integralife.com

Study Locations

• Belgium
  • Roeselare, Belgium
    • Not yet recruiting
    • AZ Delta - Roeselare
    • Contact: Dimitri Vanhauwaert, MD; Phone Number: + 32 51 237440; Email: dimitri.vanhauwaert@azdelta.be
    • Contact: Stijn Van Damme, SC; Phone Number: + 32 51 237449; Email: stijn.vandamme@azdelta.be
• Germany
  • Dortmund, Germany
    • Recruiting
    • Klinikum Dortmund Wirbelsäulenchirurgie
    • Contact: Dr. Oliver Müller
  • Düsseldorf, Germany, 40225
    • Not yet recruiting
    • Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
    • Contact: Thomas Beez, MD; Phone Number: +49 211 81 07664; Email: thomas.beez@med.uni-duesseldorf.de
    • Contact: Fljamur Aljiji, SC; Email: Fljamur.Aljiji@med.uni-duesseldorf.de
  • Essen, Germany
    • Recruiting
    • Universitätsklinikum Essen
    • Contact: Dr. Philipp Dammann
  • Freiburg, Germany
    • Recruiting
    • Freiburg University Hospital
    • Contact: Dr. Mukesch Johannes Shah
  • Stuttgart, Germany
    • Recruiting
    • Katharinenhospital - Neurochirurgische Klinik Stuttgart
    • Contact: Dr. Oliver Gandslandt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success - Time Frame: Days	Device Success is defined as: Deployment with the correct valve positioning; Original intended device in place, and; No additional surgical or interventional procedures related to access or the device since completion of the original procedure.	30 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Valve Replacement	Incidence of Valve replacement post - implantation	12, 24 and 36 Months
Adverse Events	Incidence of Adverse Events post - implantation Long term safety will be assessed by the incidence of all adverse events/complications including number of subjects with shunt and/or shunt system infections.	12, 24 and 36 Months
Number of encounters with inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves	Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation prior to MRI	12, 24 and 36 Months

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Sherese Fralin, MSN, FNP, PhD, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hypertension; Hemorrhagic Stroke; Pseudotumor Cerebri; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: C-CERTAS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No