NCT04658017

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

Feasibility of Hemodialysis With the GARNET Device in Chronic Hemodialysis Patients With a Bloodstream Infection

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Boa Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bloodstream Infection

Interventions

Type	Name	Description
DEVICE	GARNET device	Use of new filter in conjunction with standard of care dialysis.

Timeline

• Start date: 2021-03-15
• Primary completion: 2021-10-15
• Completion: 2021-12-31
• First posted: 2020-12-08
• Last updated: 2021-09-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study