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NCT01349712 Clinical Trial

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

Blood Coagulation Disorders Clinical Trial

Official title:
Correlation of Feasibility Batches Using Warfarinised Blood

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01349712
Other study ID # MOB 0158
Secondary ID
Status Unknown status
Phase N/A
First received April 29, 2011
Last updated May 5, 2011
Start date May 2011
Est. completion date November 2011

Study information
Verified date May 2011
Source Universal Biosensors Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 200
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States White River Diagnostic Clinic Batesville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Universal Biosensors Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device To determine the correlation of PT/INR values between an experimental and commercial device. Fives days to collect data and up to two weeks to generate correlation graph
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