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

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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
Enrollment 274

Recruitment Details Subjects were enrolled between September 29, 2004 and October 13, 2006. Twelve (12) investigational sites within the US enrolled 274 Subjects.
Pre-assignment Details 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.
Arm/Group Title Codman VPV System
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 274
Completed 267
Not Completed 7
Reason Not Completed
Withdrawal by Subject             2
Did not have required condition (hydroce             5
Arm/Group Title Codman VPV System
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
<=18 years
35
  13.1%
Between 18 and 65 years
90
  33.7%
>=65 years
142
  53.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 267 participants
57  (26.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
Female
137
  51.3%
Male
130
  48.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 267 participants
267
1.Primary Outcome
Title Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading
Hide Description 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".
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Codman VPV System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: Percentage of participants
98.33
2.Secondary Outcome
Title Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds
Hide Description 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)
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Codman VPV System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: Percentage of agreement
Percentage of Agreement (exact match) 63.89
Percentage of Agreement in 1 step (+/- 10 mmH20) 96.11
Percentage of Agreement >2 steps (>20 mmH20) 1.67
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Codman VPV System
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Codman VPV System
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Codman VPV System
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Codman VPV System
Affected / at Risk (%)
Total   0/0 
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.
Results Point of Contact
Name/Title: Jandira Ramos, MPH
Organization: Codman & Shurtleff, Inc.
Phone: 508-828-3127
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