CERTAS Programmable Valve Registry (CERTAS)

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

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

Study Overview

• Status: Completed
• Conditions: Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension
• Intervention / Treatment: Device: CODMAN CERTAS 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 clinical investigation specifically aims to collect data on the performance measures outlined below. Data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit.

1) Improvement of the following symptoms related to hydrocephalus:

• Gait disturbances;
• Spatial impairment;
• Cognitive abilities;
• Urinary incontinence;
• Pain caused by headaches;
• Visual acuity.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany
    • Universitatsklinikum Dusseldorf
  • Essen, Germany
    • Universitätsklinikum Essen
  • Freiburg, Germany
    • Freiburg University Hospital
  • Mannheim, Germany
    • Universitätsmedizin Mannheim
  • München, Germany, 81675
    • Klinikum rechts der Isar Technischen Universitat Munchen
  • München, Germany
    • Munchen Klinik Bogenhausen
  • Stuttgart, Germany
    • Klinikum Der Landeshauptstadt Stuttgart gKAöR
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.

Description

Inclusion Criteria:

1. Adult patients (18-80 years old at time of enrollment) undergoing implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
2. Patients willing and able to understand and sign informed consent.

Exclusion Criteria:

N/A

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 Programmable Valves; 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
Performance Endpoints	The change from baseline for the following symptoms related to hydrocephalus, e.g. gait disturbances, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headaches and visual acuity.	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Deficiencies	Incidence and nature of device deficiencies	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints: Incidence and nature of adverse device effects	Incidence and nature of adverse device effects	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Avania
• Investigators: Study Director: Sanja Ilic, MD, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: C-CERTAS-001

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
• product manufactured in and exported from the U.S.: Yes