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

Sponsored by:	Codman & Shurtleff
Information provided by:	Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00196196

Purpose

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	Intervention	Phase
Hydrocephalus Normal Pressure Hydrocephalus	Device: Codman VPV System	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus X-Rays

U.S. FDA Resources

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:

Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-Ray Reading [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-Rays Using Various Thresholds [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment:	274
Study Start Date:	September 2004
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196196

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:

Michael Ward, DVM

Codman & Shurtleff

More Information

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

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 ( Michael Ward, Worldwide Director, Clinical Research )
Study ID Numbers:	VPV-US03-001
Study First Received:	September 12, 2005
Results First Received:	November 4, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00196196 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Codman & Shurtleff:

Hydrocephalus
Codman Hakim Programmable Valve
Programmable Valve
Shunt System

Study placed in the following topic categories:

Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Nervous System Diseases
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on September 03, 2009