CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
HemoCare™ 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.

Search/NCT04087213
NCT04087213N/ACompleted

Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis

Deka Research and Development·interventional·Posted Sep 12, 2019·Updated Aug 13, 2024

In Brief

A clinical study evaluating HemoCare™ Hemodialysis System for End-Stage Renal Disease. Completed, enrolled 36 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 12, 2019
Enrollment StartSep 5, 2019
Primary CompletionJan 11, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.8 years ago

Interventions

HemoCare™ Hemodialysis Systemdevice

The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.