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Completed

NCT Number: NCT00196196

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Codman VPV System

Device

Valve Positioning Verification (VPV) System

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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