At a glance
ClinicalIndex Comparison RecordN/ACompleted· 46 enrolled
Drug / intervention
SC+ Hemodialysis Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis
In Brief
A clinical study evaluating SC+ Hemodialysis System for Renal Failure. Completed, enrolled 46 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartNov 2021
Primary CompletionOct 2023
Study CompletionNov 2024
TodayJul 2026
First PostedJul 26, 2021
Enrollment StartNov 18, 2021
Primary CompletionOct 30, 2023
Study CompletionNov 27, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago
Interventions
SC+ Hemodialysis Systemdevice
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.