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A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System

NCT04655989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-10-06

No results posted yet for this study

Summary

The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.

Conditions

  • Dialysis
  • Chronic Renal Failure

Interventions

DEVICE

DBB-EXA ES Hemodialysis System

The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Nikkiso America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-02-24
Completion
2021-05-01
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 NCT04655989 on ClinicalTrials.gov