Trials / Completed
CompletedNCT04511338
Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™
A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Fresenius Medical Care North America · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the safety and efficacy of heparin free hemodialysis (HD) performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dialyzer with Endexo | Sequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13) |
Timeline
- Start date
- 2020-11-02
- Primary completion
- 2021-05-21
- Completion
- 2021-06-16
- First posted
- 2020-08-13
- Last updated
- 2022-03-04
- Results posted
- 2022-03-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04511338. Inclusion in this directory is not an endorsement.