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

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

(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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Healthy
• Intervention / Treatment: Device: ViTrack; Device: Oscillometric BP Device; Device: Auscultatory cuff

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 91

Contacts and Locations

• Study Contact: Name: Mohan Thanikachalam, MD; Phone Number: +1 (617) 639 - 5569; Email: admin@dynocardia.care
• Study Contact Backup: Name: Gokul Prasath Rajamanickam, MS; Email: gokulpr@dynocardia.care

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Recruiting
      • Dynocardia Inc
      • Contact: Gokul Rajamanickam; Email: gokulpr@dynocardia.care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adults

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Experimental-Arm; For the same subject,; ViTrack wrist cuff is applied on one of the wrist; Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm; Auscultatory cuff is applied to the brachial artery of the same arm

Device: ViTrack; ViTrack is a continuous non-invasive wearable blood pressure cuff.; Device: Oscillometric BP Device; Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.; Device: Auscultatory cuff; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Diastolic Blood Pressure	3 sets readings compared across blood pressure (mmHg)	up to 30 minutes
Comparison of Systolic Blood Pressure	3 sets readings compared across blood pressure (mmHg)	up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Irritation	Examining for local skin irritation	Up to 72 hours

Collaborators and Investigators

• Sponsor: Dynocardia, Inc
• Investigators: Principal Investigator: Mohan Thanikachalam, MD, Dynocardia, Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Blood Pressure, Cuff less, Wearable, BP
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: TBPI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Personal and medical information will stay confidential and secure and will be protected in accordance with current US law. All participants will be provided with a unique ID number. All participants' information such as participants' name and address as well as background information will be de-identified to protect subject confidentiality.

Dynocardia or its designees will comply with all relevant data collection laws when collecting data for this study. Study databases will not include the participants name or address. Images will be captured by ViTrack under patient's ID in an electronic database. All other data will be de-identified for review purpose and transferred via a secure method.

• IPD Sharing Time Frame: Data will become available following data analysis within 6 month of study completion and will remain available for up to 3 years.
• IPD Sharing Access Criteria: Data will be accessed via secure methods outlined in a data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes