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

NCT05540457 | Completed FDA Device

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  7 days from start of participation

Secondary Outcomes (2)

• Intradialytic Blood Pressure Events

  7 days from start of participation

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

  7 days from start of participation

Study Arms (1)

Non-Invasive Blood Pressure (NIPB)Monitors

EXPERIMENTAL

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

Intermittent Non-InvasiveBlood Pressure Monitor DEVICE

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.

Non-Invasive Blood Pressure (NIPB)Monitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Rogosin Institute: lead
• Outset Medical: collaborator
• CareTaker Medical LLC: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Liu, MD

  The Rogosin Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: September 14, 2022
• Study Start: September 22, 2022
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)