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COMPLETEDNCT04207229

CERTAS Programmable Valve Registry

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

Lead sponsor: Integra LifeSciences Corporation•8 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Integra LifeSciences Corporation

Collaborators

Avania

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.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 26, 2022Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment35

Start dateNov 2019

Last updatedJan 26, 2022

Condition

Hydrocephalus NPH (Normal Pressure Hydrocephalus)IIH - Idiopathic Intracranial Hypertension

Locations shown

Universitätsklinikum Düsseldorf

Düsseldorf

UniversitätsKlinikum Essen

Essen

Freiburg University Hospital

Freiburg im Breisgau

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2022Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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