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

Study Overview
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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.

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.

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

Conditions
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Hydrocephalus, Normal Pressure Hydrocephalus

Intervention / Treatment
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* Device: Codman VPV System


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Codman VPV System|Valve Positioning Verification (VPV) System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrocephalus, Codman Hakim Programmable Valve, Programmable Valve, Shunt System