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Comparison of Non-Invasive Blood Pressure Methods

NCT04296227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2020-05-13

Study results available
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Summary

The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.

The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Conditions

  • Blood Pressure

Interventions

DEVICE

The Vital Detect blood pressure monitor

The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Vital USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Batchelder · Clinimark Laboratory Services

  • Dena M Raley · Clinimark Laboratory Services

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2020-03-03
Completion
2020-03-03
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 NCT04296227 on ClinicalTrials.gov