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Blood Flow Effects on Silicon Substrates

NCT03241667 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-02-28

No results posted yet for this study

Summary

This is a non-randomized, open label, uncontrolled first in human safety study, testing the the material used in the artificial kidney device in subjects already on hemodialysis.

Six subjects already on hemodialysis, who meet the study inclusion and exclusion criteria, and who dialyze at one of the UCSF associated hemodialysis units will be recruited. Each subject will be tested during one non hemodialysis day, at the UCSF Moffitt-Long Hospital Acute Hemodialysis Unit (AHU).

The artificial kidney engineers have created a blood flow system that can be substituted for the dialysis filter in a standard hemodialysis machine. This is NOT a dialysis filter. It allows the subjects blood to come in contact with the material while the blood is being circulated as is regularly done during a hemodialysis session.

Conditions

  • ESRD

Interventions

DEVICE

HemoCartridge

Our goal is to apply MEMS (microelectromechanical systems) and nanotechnology to miniaturize the bioartificial kidney (BAK) into an implantable, self-monitoring, and self-regulating renal surrogate. The implantable BAK (iBAK) is a biocompatible cartridge containing stacks of hemofilter membranes (HemoCartridge) and renal tubule cell bioreactors (BioCartridge) combined to mimic nephron function. Here, we plan to test ONLY the material being used to construct the HemoCartridge, to be sure in humans when substituted for a standard hemodialysis filter, subjects don't develop any clinical problems or side effects during several hours of blood exposure to the material. The AK material will be engineered by the study team to allow the system to be substituted in place of a standard HD filter.

Sponsors & Collaborators

Principal Investigators

  • Shuvo Roy, PhD · University of California, San Francisco

Eligibility

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

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-02-15
Completion
2020-06-30
FDA Device
Yes

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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 NCT03241667 on ClinicalTrials.gov