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Device

Blood Pressure Monitoring for Kidney Failure

N/A
Waitlist Available
Research Sponsored by The Rogosin Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
Participant weighs ≥ 34kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days from start of participation
Awards & highlights

Study Summary

This trial is testing a new hemodialysis system and monitor in people with end-stage kidney disease. The trial is open label, which means that participants and researchers will know which treatment the participants are receiving. The trial is non-randomized, which means that participants will not be assigned to different groups by chance. The trial is post-market, which means that the new system and monitor have already been approved for use.

Who is the study for?
This trial is for adults over 18 with end-stage kidney disease who are on maintenance dialysis and weigh at least 34kg. They must be able to give informed consent and sign a privacy agreement. It's not suitable for those whose arms can't fit the blood pressure cuffs or have poor blood flow in their lower arm and hand.Check my eligibility
What is being tested?
The study is evaluating how well two types of non-invasive blood pressure monitors work during dialysis: one that measures continuously and another that measures intermittently, using the Tablo Hemodialysis System alongside the VitalStream Monitor.See study design
What are the potential side effects?
Since this trial focuses on monitoring equipment rather than medication, traditional side effects aren't expected. However, discomfort from wearing the monitor cuffs could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18, have given my consent, and signed a HIPAA form.
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I weigh at least 34kg.
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I have advanced kidney disease and am on regular dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days from start of participation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days from start of participation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-invasive Blood Pressure Monitor (NIPB) Measurements
Secondary outcome measures
Intradialytic Blood Pressure Events
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-Invasive Blood Pressure (NIPB)MonitorsExperimental Treatment1 Intervention
NIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis. VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittent Non-InvasiveBlood Pressure Monitor
2022
N/A
~10

Find a Location

Who is running the clinical trial?

Outset MedicalIndustry Sponsor
5 Previous Clinical Trials
1,062 Total Patients Enrolled
CareTaker Medical LLCIndustry Sponsor
5 Previous Clinical Trials
376 Total Patients Enrolled
The Rogosin InstituteLead Sponsor
30 Previous Clinical Trials
3,542 Total Patients Enrolled

Frequently Asked Questions

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

Does this research endeavor currently have open slots for participants?

"According to clinicaltrials.gov, this trial is still open for enrollment. It was first published on September 22nd 2022 and had an updated version available as of the 30th of that month."

Answered by AI

What is the approximate size of this trial's participant pool?

"Affirmative. The clinical trial's availability is confirmed on the clinicaltrials.gov website, which was initially uploaded to on September 22nd 2022 and most recently updated on the thirtieth of September 2022. Currently 10 individuals are being sought from a single medical centre for this experiment."

Answered by AI
~4 spots leftby Mar 2025