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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
Results First Received: November 4, 2008  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hydrocephalus
Normal Pressure Hydrocephalus
Intervention: Device: Codman VPV System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 274 Subjects enrolled, 5 were determined to be ineligible - did not have hydrocephalus, a required condition per inclusion/exclusion criteria. Two (2) Subjects withdrew early. Overall, 267 Subjects were eligible for analysis.

Reporting Groups
  Description
Codman VPV System No text entered.

Participant Flow:   Overall Study
    Codman VPV System  
STARTED     274  
COMPLETED     267  
NOT COMPLETED     7  
Withdrawal by Subject                 2  
Did not have required condition (hydroce                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Codman VPV System No text entered.

Baseline Measures
    Codman VPV System  
Number of Participants  
[units: participants]
 		  267  
Age  
[units: participants]
 		 
<=18 years     35  
Between 18 and 65 years     90  
>=65 years     142  
Age  
[units: years]
Mean ± Standard Deviation 		  57  ± 26.1  
Gender  
[units: participants]
 		 
Female     137  
Male     130  
Region of Enrollment  
[units: participants]
 		 
United States     267  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading   [ Time Frame: Day 1 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds   [ Time Frame: Day 1 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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