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

NCT00196196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2012-05-28

Study results available
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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.

Conditions

  • Hydrocephalus
  • Normal Pressure Hydrocephalus

Interventions

DEVICE

Codman VPV System

Valve Positioning Verification (VPV) System

Sponsors & Collaborators

  • Codman & Shurtleff

    lead INDUSTRY

Principal Investigators

  • J. Thomas Megerian, MD · Codman & Shurtleff

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196196 on ClinicalTrials.gov