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Study to Test the Accuracy of a Prototype Handheld PT/INR Device

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Universal Biosensors Pty Ltd.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01349712
First Posted: May 9, 2011
Last Update Posted: October 12, 2017
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.
Information provided by:
Universal Biosensors Pty Ltd
April 29, 2011
May 9, 2011
October 12, 2017
May 2011
November 2011   (Final data collection date for primary outcome measure)
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device [ Time Frame: Fives days to collect data and up to two weeks to generate correlation graph ]
To determine the correlation of PT/INR values between an experimental and commercial device.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Test the Accuracy of a Prototype Handheld PT/INR Device
Correlation of Feasibility Batches Using Warfarinised Blood
The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.
This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects currently receving coumadin(warfarin) treatment
Blood Coagulation Disorders
Not Provided
Coumadin (warfarin)
Subjects are required to be currently receiving coumadin (warfarin) treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently taking coumadin (warfarin)
  • Aged 18 years or older
  • Able and willing to provide informed consent
  • Can understand (read and write) English

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01349712
MOB 0158
No
Not Provided
Not Provided
Richard Ward, Assistant Professor, College of Pharmacy Harding University
Universal Biosensors Pty Ltd
Not Provided
Principal Investigator: Richard Ward, Pharm D Harding University
Universal Biosensors Pty Ltd
May 2011