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Device

GARNET device for Bloodstream Infection

N/A
Waitlist Available
Research Sponsored by Boa Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-day follow-up post-2nd garnet device treatment
Awards & highlights

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.

Eligible Conditions
  • Bloodstream Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-day follow-up post-2nd garnet device treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-day follow-up post-2nd garnet device treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety - Rate of adjudicated device- or GARNET device procedure-related Serious Adverse Events (SAEs)
Secondary study objectives
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.
Resolution of Blood Stream Infection at 30-days post 2nd GARNET device treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: GARNET deviceExperimental Treatment1 Intervention
All enrolled subjects will receive treatment with the GARNET device.

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Who is running the clinical trial?

Boa Biomedical, Inc.Lead Sponsor
AvaniaIndustry Sponsor
51 Previous Clinical Trials
9,457 Total Patients Enrolled
~3 spots leftby Sep 2025
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