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

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ClinicalTrials.gov Identifier: NCT00196196
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : December 5, 2008
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus X-Rays

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, Older Adult
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: J. Thomas Megerian, MD Codman & Shurtleff
More Information
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Publications:
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

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00196196     History of Changes
Other Study ID Numbers: VPV-US03-001
First Posted: September 20, 2005    Key Record Dates
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