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Clinical Trial Summary

To evaluate the feasibility of performing combined hemodialysis with the GARNET device in chronic hemodialysis patients with a blood stream infection (BSI), and measure clinical performance and safety endpoints.


Clinical Trial Description

This is a prospective, multi-center, single- arm study. Each subject will receive two (2) sessions of hemodialysis with the GARNET each of 3-4 hour duration at a blood flow rate of 250 to 400 mL/min. Any necessary dialysis treatment dosing prescription changes will be made by the treating physician, based on results of small molecule clearance (i.e., urea reduction ratio (URR)). After the second treatment session with the GARNET device, the subjects will resume their hemodialysis regimen using a standard hemodialyzer. Subjects will be followed for 30 days after the final treatment session to evaluate safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04658017
Study type Interventional
Source Boa Biomedical, Inc.
Contact Nisha V Varma
Phone 617-963-8990
Email nvarma@miraki.com
Status Recruiting
Phase N/A
Start date March 15, 2021
Completion date December 31, 2021

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