A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-10-31

Brief Summary

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The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation with respect to the valve adjustment process.

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Detailed Description

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Patients with Hydrocephalus, managed with an implanted Codman HakimTM Programmable Valve (CHPV), occasionally visit their physician to have their valve adjusted to a different setting to manage their condition. After the adjustment, an x-ray of the skull is taken to confirm the valve setting.

The Codman VPV System is designed to facilitate and confirm the adjustment of a CHPV. After signing the informed consent, Subjects will be enrolled in the study and have their CHPV adjusted using the Codman VPV System. After the adjustment, an x-ray of the skull will be taken to verify the valve setting. No further follow up visit is needed after the adjustment.

This study is expected to enroll about 300 Subjects from up to 20 sites in the United States.

Conditions

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Hydrocephalus Normal Pressure Hydrocephalus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Codman VPV System

Valve Positioning Verification (VPV) System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A CODMAN Hakim Programmable Valve (CHPV) has been implanted for the management of the Subject's Hydrocephalus.
* The Subject has given written informed consent prior to enrolling in the study.
* The Subject requires adjustment of the CODMAN Hakim Programmable Valve (CHPV) for the management of Hydrocephalus·
* The Subject's implanted CHPV will be adjusted using the Implanted Valve Mode.

Exclusion Criteria

* The Subject's valve is located in the deep lumbar position.
* The Subject has an open and/or recent wound site in the region of the implanted valve.
* The Subject has a history of Ultrasound gel allergies.
* The Subject is a prisoner.
* The subject has been previously enrolled in this protocol.

Eligible Sex

ALL

Accepts Healthy Volunteers

No