Trials / Completed
CompletedNCT03109574
Access in Dialysis for Better Outcomes in Patient Therapy
A Pragmatic Multicenter Pilot Trial Evaluating the Cost-Effectiveness of BioFlo DuraMax Hemodialysis Catheter vs Standard of Care Catheter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- William Osler Health System · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioFlo DuraMax Chronic Hemodialysis Catheter | |
| DEVICE | Standard of Care Catheter |
Timeline
- Start date
- 2016-08-29
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
- First posted
- 2017-04-12
- Last updated
- 2019-11-05
Locations
3 sites across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03109574. Inclusion in this directory is not an endorsement.