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

NCT04835857 | Recruiting FDA Device

• 1 other identifier: TBPI001
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Healthy

Keywords

Blood Pressure, Cuff less, Wearable, BP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Skin Irritation

  Up to 72 hours

Study Arms (1)

Experimental-Arm

For the same subject, 1. ViTrack wrist cuff is applied on one of the wrist 2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm 3. Auscultatory cuff is applied to the brachial artery of the same arm

Device: ViTrack; Device: Oscillometric BP Device; Device: Auscultatory cuff

Interventions

ViTrack DEVICE

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

Experimental-Arm

Oscillometric BP Device DEVICE

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

Experimental-Arm

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.

Experimental-Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dynocardia, Inc: lead

Study Sites (1)

Dynocardia Inc

Newton, Massachusetts, 02459, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mohan Thanikachalam, MD

  Dynocardia, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Thanikachalam, MD

CONTACT

+1 (617) 639 - 5569; admin@dynocardia.care

Gokul Prasath Rajamanickam, MS

CONTACT

gokulpr@dynocardia.care

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available following data analysis within 6 month of study completion and will remain available for up to 3 years.
• Access Criteria: Data will be accessed via secure methods outlined in a data sharing agreement

Locations

US (1)