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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04658017
Other study ID # 700-00002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date December 31, 2021

Study information

Verified date September 2021
Source Boa Biomedical, Inc.
Contact Nisha V Varma
Phone 617-963-8990
Email nvarma@miraki.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


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Study Design


Intervention

Device:
GARNET device
Use of new filter in conjunction with standard of care dialysis.

Locations

Country Name City State
United States University of Maryland at Baltimore Baltimore Maryland
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Houston Methodist Houston Texas
United States Oregon Health and Science University Portland Oregon
United States George Washington University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Boa Biomedical, Inc. Avania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety - Rate of adjudicated device- or GARNET device procedure-related Serious Adverse Events (SAEs) Rate of adjudicated device or GARNET device procedure-related Serious Adverse Events (SAEs) All primary safety endpoints will be reported as adjudicated by the designated Clinical Events Committee (CEC) during treatment and through the 30-day follow-up period. 30-day follow-up post-2nd GARNET device treatment
Secondary Resolution of Blood Stream Infection at 30-days post 2nd GARNET device treatment • Resolution of Blood Stream Infection 30-day follow-up post-2nd GARNET device treatment
Secondary Clearance for small (blood urea nitrogen) and middle (beta-2-microglobulin) molecule solutes by the GARNET device, as measured by the intra-dialytic urea and beta-2-microglobulin reduction ratio. • Extent of clearance of solutes (small and middle molecules) During Week 1 participation - Day 0: pre and post first GARNET device treatment and pre and post second GARNET device treatment which must occur by Day 7.
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