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Abstract
Grant Number: 5R44HL067001-03 PI Name: LAW, WAI T. PI Email: wailaw@portascience.com PI Title: Project Title: Development of a non-instrumental Prothrombin Time test Abstract: DESCRIPTION (provided by applicant): Development of a disposable non-instrumented prothrombin time (PT) test for home use is proposed. Phase I data using flow channels built with precision woven fabric demonstrated the potential of the proposed test device. The blood flow endpoints formed due to clotting were repeatable, easy to read, and showed good correlation between PT and bar length. A simple and accurate disposable device is potentially a powerful tool to help patients monitor their PT at home. The specific objectives of this research are to: 1) finalize the design of the scale-up prototype device, 2) develop protocols to obtain scale-up and pilot production devices, 3) conduct clinical trials to evaluate the quality of the devices, and 4) submit data for FDA market approval. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE
Thesaurus Terms:
biomedical equipment development, consumable /disposable biomedical equipment, material, patient monitoring device, prothrombin time
blood flow measurement, clinical trial, home health care, thromboplastin
bioengineering /biomedical engineering, human subject, human tissue, patient oriented research
Institution: PORTASCIENCE, INC. 337 TOM BROWN RD MOORESTOWN, NJ 08057 Fiscal Year: 2003 Department: Project Start: 05-SEP-2000 Project End: 31-JAN-2005 ICD: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE IRG: ZRG1
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