Trials / Completed
CompletedNCT04975880
Quanta Home Run Trial
A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Quanta Dialysis Technologies Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.
Detailed description
This clinical trial is being conducted to evaluate the Quanta SC+ hemodialysis System for home use by patients with established kidney failure. A dialysis prescription of 3 sessions per week, 4 hours per session, or facility standard will be provided during the in-clinic training period, followed by the home period with a dialysis prescription of 4 sessions per week, 3.5 hours per session.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SC+ Hemodialysis System | Following the in-clinic training phase and one week transition, the intervention of self or care partner hemodialysis delivered in the home setting will occur for 8 weeks. |
Timeline
- Start date
- 2021-11-18
- Primary completion
- 2023-10-30
- Completion
- 2024-11-27
- First posted
- 2021-07-26
- Last updated
- 2024-12-19
- Results posted
- 2024-12-03
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04975880. Inclusion in this directory is not an endorsement.