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Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD

End-Stage Renal Disease Clinical Trial

Official title:
Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis

Clinical Trial Summary

This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.

Clinical Trial Description

The HemoCare™ Hemodialysis System has been evaluated in previous clinical trials and is designed to perform hemodialysis (HD) in a clinic setting, in a self-care setting, or in a home environment for conventional HD, short daily HD or extended-duration HD therapy during the daytime or at night dependent on the users' lifestyle or work schedule. This multi-center, open-label, single-arm cross-over study is designed specifically to gather and evaluate safety data for the use of the HemoCare™ Hemodialysis System (including labeling and training tools) during home nocturnal (during sleeping hours based on the patient schedule) use. Nocturnal HD therapy was chosen as a treatment in this study because of the clinical and humanistic benefits associated with it. In addition, its risk profile, especially when performed in a home setting, may be greater than either existing conventional or short daily HD therapies. In this regard, establishing an acceptable safety profile for home nocturnal HD therapy should be sufficient evidence to support conventional and short daily HD home therapies with HemoCare™ Hemodialysis System. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04087213
Study type Interventional
Source Deka Research and Development
Contact
Status Completed
Phase N/A
Start date September 5, 2019
Completion date January 11, 2023
View Details
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