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Device

HemoCare Hemodialysis for Kidney Failure

N/A
Waitlist Available
Research Sponsored by Deka Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a trained study care partner able to support subject for all at-home study treatments.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial will monitor patients who use the HemoCare Hemodialysis System to see if it is safe.

Who is the study for?
This trial is for individuals with chronic kidney failure who have used the HemoCare™ Hemodialysis System and can follow study requirements. They need a supportive care partner, stable vascular access, and must understand English. Pregnant or planning to become pregnant soon, significant other medical conditions or psychiatric disorders that could affect participation are reasons for exclusion.Check my eligibility
What is being tested?
The safety of the HemoCare™ Hemodialysis System is being tested in patients who require ongoing treatment for kidney failure. This open-label study allows participants continued use while pre-market evaluations are conducted.See study design
What are the potential side effects?
While specific side effects aren't listed here, hemodialysis systems like HemoCare™ may cause low blood pressure, muscle cramps, itching, sleep problems, anemia or infection at the dialysis site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have someone to help me with my treatment at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Measures

Trial Design

1Treatment groups
Experimental Treatment
Group I: The HemoCare™ Hemodialysis SystemExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HemoCare™ Hemodialysis System
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Deka Research and DevelopmentLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
CVS Kidney Care LLC.UNKNOWN
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

HemoCare™ Hemodialysis System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04198012 — N/A
Kidney Failure Research Study Groups: The HemoCare™ Hemodialysis System
Kidney Failure Clinical Trial 2023: HemoCare™ Hemodialysis System Highlights & Side Effects. Trial Name: NCT04198012 — N/A
HemoCare™ Hemodialysis System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04198012 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are current recruitment efforts still underway for this research trial?

"As reported on clinicaltrials.gov, this experiment is not currently recruiting any new participants; it was initially advertised in December 16th 2019 and ammended most recently on November 23rd 2022. While no fresh candidates are being accepted for the trial at present, 180 other trials presently require volunteers."

Answered by AI

How many centers are offering this research project?

"This trial is currently taking place at 7 sites, including Knoxville and Austin. To minimise the burden of travel for participants, it's advised to choose a clinic closest to you if enrolling in this study."

Answered by AI
Recent research and studies
~0 spots leftby May 2024