CERTAS Programmable Valve Registry

N/ACompletedNCT04207229

Integra LifeSciences Corporation35 enrolled

Overview

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

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

Conditions

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

Interventions

CODMAN CERTAS Programmable ValvesDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (8)

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

UniversitätsKlinikum Essen

Essen, Germany

Freiburg University Hospital

Freiburg im Breisgau, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Outcomes

Primary Outcomes

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.

Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Secondary Outcomes

Device Deficiencies

Incidence and nature of device deficiencies

Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Data from ClinicalTrials.gov

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