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GARNET™ Filter (GARNET Device) IDE Used in Chronic Hemodialysis Patients With a Bloodstream Infection

NCT04658017 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-09-05

No results posted yet for this study

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.

Conditions

  • Bloodstream Infection

Interventions

DEVICE

GARNET device

Use of new filter in conjunction with standard of care dialysis.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Boa Biomedical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2021-10-15
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658017 on ClinicalTrials.gov