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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00196196
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : December 5, 2008
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hydrocephalus
Normal Pressure Hydrocephalus
Intervention: Device: Codman VPV System

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Codman VPV System No text entered.

Baseline Measures
   Codman VPV System 
Overall Participants Analyzed 
[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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jandira Ramos, MPH
Organization: Codman & Shurtleff, Inc.
phone: 508-828-3127
e-mail: jramos8@its.jnj.com


Publications:

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00196196     History of Changes
Other Study ID Numbers: VPV-US03-001
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: November 4, 2008
Results First Posted: December 5, 2008
Last Update Posted: May 28, 2012