Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

Last updated: August 5, 2024
Sponsor: Dynocardia, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Circulation Disorders

Stress

Treatment

ViTrack

Auscultatory cuff

Oscillometric BP Device

Clinical Study ID

NCT04835857
TBPI001
  • Ages 18-90
  • All Genders

Study Summary

(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Health volunteers 18 years and above; equal numbers of males and females to addressSex As a Biological Variable (SABV); and in sinus rhythm.

  • Agree to commit to participate in the current protocol.

  • Provide written informed consent prior to any study procedures being performed (allsubjects should be able to understand the informed consent form and any otherdocuments that subjects are required to read).

Exclusion

Exclusion Criteria:

  • Unable or unwilling to provide informed consent

  • Any other condition that would increase the risk of participation in the study inthe opinion of the site Investigator.

  • A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.

  • Upper extremity arteriovenous hemodialysis shunt.

  • Wrist distortion or pain from arthritis.

  • Prior trauma or surgery at the radial artery monitoring site.

Study Design

Total Participants: 91
Treatment Group(s): 3
Primary Treatment: ViTrack
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
December 21, 2025

Study Description

(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.

Connect with a study center

  • Dynocardia Inc

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.