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Quanta Home Run Trial

NCT04975880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-19

Study results available
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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.

Conditions

  • Renal Failure

Interventions

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.

Sponsors & Collaborators

  • Quanta Dialysis Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Paul Komenda, MD · Quanta Dialysis Technology

  • Christopher T Chan, MD · University of Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2023-10-30
Completion
2024-11-27
FDA Device
Yes

Countries

  • United States

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 NCT04975880 on ClinicalTrials.gov