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

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Hydrocephalus
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Joanne Kurtzberg, MD – Hydrocephalus
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Brief Title

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

Official Title

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

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.

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading

Secondary Outcome

 Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds

Condition

Hydrocephalus

Intervention

Codman VPV System

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

274

Start Date

September 2004

Completion Date

October 2006

Primary Completion Date

October 2006

Eligibility 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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

J. Thomas Megerian, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00196196

Organization ID

VPV-US03-001

Responsible Party

Sponsor

Study Sponsor

Codman & Shurtleff

Study Sponsor

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

Verification Date

February 2011