CERTAS Programmable Valve Registry

Completed

• Conditions: Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension
• Interventions: Device: CODMAN CERTAS Programmable Valves

• Registration Number: NCT04207229
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus 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 Timeline

• Study Start: 2019-11-21
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CODMAN CERTAS Programmable Valves	CODMAN CERTAS Programmable Valves	CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Primary Outcome Measures

Name	Time	Method
Performance Endpoints	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Device Deficiencies	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months	Incidence and nature of device deficiencies

Trial Locations

Locations (8)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

UniversitätsKlinikum Essen; 🇩🇪 Essen, Germany

Freiburg University Hospital; 🇩🇪 Freiburg, Germany

Klinikum der LandesHauptStadt Stuttgart gKAôR; 🇩🇪 Stuttgart, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Klinikum rechts der Isar Technischen Universitat München; 🇩🇪 München, Germany

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Germany

München Klinik Bogenhausen; 🇩🇪 München, Germany