ClinicalTrials.gg
CompletedNCT05540457Updated Jun 11, 2025

Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)

An interventional study of Intermittent Non-InvasiveBlood Pressure Monitor in End Stage Renal Disease, End Stage Renal Disease on Dialysis and Dialysis Hypotension, sponsored by The Rogosin Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by The Rogosin Institute · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Feb 2024, 2 years 9 months ago, and no results have been posted to the registry.

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Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 765 studies in Kidney Failure, Chronic with a site in United States — 65 open to participants now, 97 under way, 9 of them phase 3. Kidney Failure, Chronic · United States.

Enrollment
542nd of 638
10 · median 48
Started
2022
with 32 others
No phase
287 of 765
28 open now
Registered
675th of 765
by date

Among the 765 studies in Kidney Failure, Chronic with a site in United States, this one is the 542nd largest by enrollment of the 638 interventional ones that give a count, is one of 33 that started in 2022, is one of 287 with no phase, and was the 675th registered.

Kidney Failure, Chronic

2,109 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

Browse Kidney Failure, Chronic studies →

Open to participants now

65 of the 765 studies in Kidney Failure, Chronic with a site in United States are open now. Recruiting first, the newest first:

60 more — sign in →

All 65 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 169 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.

03

Conditions studied

  • End Stage Renal Disease
  • End Stage Renal Disease on Dialysis
  • Dialysis Hypotension
  • Dialysis Induced Hypertension

Keywords

  • Tablo
  • Outset Medical, Inc.
  • Caretaker Medical, LLC
  • VitalStream
  • ESKD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant is at least 18 years of age and has provided and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
  • Participant weighs ≥ 34kg.
  • Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.

Exclusion criteria

Exclusion Criteria:

  • Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
  • The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Non-Invasive Blood Pressure (NIPB)Monitors

    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.

    Device: Intermittent Non-InvasiveBlood Pressure Monitor

Interventions

  • DeviceIntermittent Non-InvasiveBlood Pressure Monitor

    Brachial cuff integrated with theTablo Hemodialysis System. Cuffwill be placed contralateral to theaccess arm, with measurementscollected pre-dialysis, every 30minutes during dialysis, and post-dialysis. Device: Continuous Non-InvasiveBlood Pressure Monitor VitalStream Monitor. Finger cuffwill be placed ipsilateral to theaccess arm, with measurementscollected pre-dialysis,continuously during dialysis, andpost-dialysis.

06

What researchers measure

Primary outcomes

  1. Non-invasive Blood Pressure Monitor (NIPB) Measurements

    Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.

    Time frame: 7 days from start of participation

Secondary outcomes

  1. Intradialytic Blood Pressure Events

    Summary of observed intradialytic BP events (hypertensive andhypotensive)

    Time frame: 7 days from start of participation

  2. Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)

    Participant Preference Questionnaire (PPQ)

    Time frame: 7 days from start of participation

07

Study locations

1 site
  • The Rogosin Institute
    New York, New York 10019, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Feb 2024, 16 months.

Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 16 months is below that.

Counting every sponsor, half of 425 studies reached it within 22 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2022
First posted
Sep 14, 2022
StartActual
Sep 22, 2022
Primary completionActual
Feb 9, 2024
CompletionActual
Feb 9, 2024
Last update
Jun 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05540457
Lead sponsor
The Rogosin Institute
Collaborators
Outset Medical, CareTaker Medical LLC
Responsible party
Sponsor
First posted
Sep 14, 2022
Start date
Sep 22, 2022
Primary completion
Feb 9, 2024
Completion
Feb 9, 2024
Last update
Jun 11, 2025

Study contacts

Frank Liu, MD
principal investigator · The Rogosin Institute, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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