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

NCT04087213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-13

Study results available
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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.

Conditions

  • End-Stage Renal Disease

Interventions

DEVICE

HemoCare™ Hemodialysis System

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.

Sponsors & Collaborators

  • CVS Kidney Care LLC.

    collaborator UNKNOWN

  • Deka Research and Development

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2023-01-11
Completion
2023-01-11
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 NCT04087213 on ClinicalTrials.gov