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Access in Dialysis for Better Outcomes in Patient Therapy

NCT03109574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-11-05

No results posted yet for this study

Summary

This is a prospective, multi-center health economic study in Canada. Participants will be randomly assigned to receive either the study or control dialysis catheter. The primary objective is to evaluate resource utilization in Ontario related to hemodialysis catheter placement including tissue plasminogen activator (tPA) usage, catheter exchange rates, catheter patency, and missed dialysis days.

Conditions

  • Central Venous Catheter
  • Catheter-Related Bloodstream Infection (CRBSI) Nos

Interventions

DEVICE

BioFlo DuraMax Chronic Hemodialysis Catheter

DEVICE

Standard of Care Catheter

Sponsors & Collaborators

  • Angiodynamics, Inc.

    collaborator INDUSTRY

  • William Osler Health System

    lead OTHER

Principal Investigators

  • Sandra Donnelly, MD · William Osler Health System

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Device
Yes

Countries

  • Canada

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 NCT03109574 on ClinicalTrials.gov