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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00196196
First received: September 12, 2005
Last updated: May 22, 2012
Last verified: February 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]
    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:
  • 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 ]
    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)


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)
Intervention Details:
    Device: Codman VPV System
    Valve Positioning Verification (VPV) System
    Other Name: Codman VPV System
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: J. Thomas Megerian, MD Codman & Shurtleff
  More Information

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

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00196196     History of Changes
Other Study ID Numbers: VPV-US03-001
Study First Received: September 12, 2005
Results First Received: November 4, 2008
Last Updated: May 22, 2012
Health Authority: United States: Institutional Review Board

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
Intracranial Hypertension

ClinicalTrials.gov processed this record on May 21, 2013