This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. It is our hypothesis that pain following liver biopsy results from bleeding following withdrawal of the biopsy needle from the liver which leaves an open track causing variable degrees of bleeding. This bleeding causes discomfort to the patient with possible additional procedural and hospitalization costs due to prolonged stays and analgesic medication use. In rare instances, bleeding may be life threatening.
The specific aim of this part of the Phase II SBIR is to evaluate the hemostatic biopsy device in humans to evaluate its efficacy in limiting post liver biopsy bleeding and pain. Based on prior experimental work in a the anti-coagulated canine liver and the cirrhotic swine liver, we hypothesize that the device will obtain a satisfactory tissue core sample and deliver a plug of Avitene coagulant into the track to minimize arterial or portal venous bleeding or surface oozing in humans and reduce post-procedure pain. Subjects will be randomized to either receive their liver biopsy using the standard liver biopsy needle system or the investigational biopsy device. Safety measurements will include serial hematocrits, pain scale evaluations, and follow up ultrasound evaluations of all patients. By testing the device under typical circumstances of bedside percutaneous biopsy, we will be able to determine the efficacy and practical utility of the device in decreasing post-procedure pain that is thought to be due to surface bleeding from the biopsy site.
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