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NCT Number: NCT04835857

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

(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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dynocardia Inc

Newton, Massachusetts, 02459, United States

Location status: Recruiting

Location contact

Gokul Rajamanickam

CONTACT

[email protected]

About this study

(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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health volunteers 18 years and above; equal numbers of males and females to address Sex 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 (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Exclusion criteria

  • Unable or unwilling to provide informed consent
  • Any other condition that would increase the risk of participation in the study in the 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.

Treatment and study plan

ViTrack

Device

ViTrack is a continuous non-invasive wearable blood pressure cuff.

Oscillometric BP Device

Device

Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.

Auscultatory cuff

Device

The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.

Primary outcomes

  1. Comparison of Diastolic Blood Pressure

    Time frame: up to 30 minutes

    3 sets readings compared across blood pressure (mmHg)

  2. Comparison of Systolic Blood Pressure

    Time frame: up to 30 minutes

    3 sets readings compared across blood pressure (mmHg)

Secondary outcomes

  1. Skin Irritation

    Time frame: Up to 72 hours

    Examining for local skin irritation

Study contacts

Contact information is provided by the study sponsor or research team.

Gokul Prasath Rajamanickam, MS

CONTACT

[email protected]

Mohan Thanikachalam, MD

CONTACT

[email protected]

+1 (617) 639 - 5569

Sponsors and collaborators

Lead sponsor

Dynocardia, Inc

Industry

Registry information

Official study title

Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2021
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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