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

Phase 3CompletedNCT00196196

Codman & Shurtleff274 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

274

Conditions

Hydrocephalus Normal Pressure Hydrocephalus

Interventions

Codman VPV SystemDEVICE

Valve Positioning Verification (VPV) System

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (8)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Newark, New Jersey, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading

Up to 5 attempts to achieve "Adjustment Complete" using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered "consensus X-ray". All participants included achieved "Adjustment Complete" and a "consensus X-ray reading".

Time frame: Day 1

Secondary Outcomes

Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds

Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = \>20 mmH20)

Time frame: Day 1

Data from ClinicalTrials.gov

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