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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hydrocephalus; Normal Pressure Hydrocephalus	Device: Codman VPV System	Phase 3

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	274 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Study Start Date :	September 2004
Actual Primary Completion Date :	October 2006
Actual Study Completion Date :	October 2006

Arms and Interventions

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Intervention Details:

Device: Codman VPV System
Valve Positioning Verification (VPV) System

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading [ Time Frame: Day 1 ]
   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".

Secondary Outcome Measures :

1. Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds [ Time Frame: Day 1 ]
   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)

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Phoenix, Arizona, United States
United States, Florida
Orlando, Florida, United States
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New Jersey
Newark, New Jersey, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
Richardson, Texas, United States

Sponsors and Collaborators

Codman & Shurtleff

Investigators

Study Director:	J. Thomas Megerian, MD	Codman & Shurtleff

More Information

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Publications:

Bret P, Guyotat J, Ricci AC, Mottolese C, Jouanneau E. [Clinical experience with the Sp[hy adjustable valve in the treatment of adult hydrocephalus. A series of 147 cases]. Neurochirurgie. 1999 May;45(2):98-108; discussion 108-9. French.

Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science Ltd: 90-91

American Society of Radiologic Technologists, Statement on IOM Report, "To Err Is Human: Building a Safer Health System", www.asrt.org/other_categories/government_relations/iom_report.htm

Pollack IF, Albright AL, Adelson PD. A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group. Neurosurgery. 1999 Dec;45(6):1399-408; discussion 1408-11.

Rohde V, Mayfrank L, Ramakers VT, Gilsbach JM. Four-year experience with the routine use of the programmable Hakim valve in the management of children with hydrocephalus. Acta Neurochir (Wien). 1998;140(11):1127-34.

Zemack G, Romner B. Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg. 2000 Jun;92(6):941-8.

Responsible Party:	Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00196196 History of Changes
Other Study ID Numbers:	VPV-US03-001
First Posted:	September 20, 2005
Results First Posted:	December 5, 2008
Last Update Posted:	May 28, 2012
Last Verified:	February 2011

Keywords provided by Codman & Shurtleff:

Hydrocephalus; Codman Hakim Programmable Valve; Programmable Valve; Shunt System

Additional relevant MeSH terms:

Hydrocephalus; Hydrocephalus, Normal Pressure; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases