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

NCT ID: NCT04835857

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-11-30

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.

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.

Conditions

Hypertension; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

ViTrack

Intervention Type: DEVICE

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

Oscillometric BP Device

Intervention Type: DEVICE

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

Auscultatory cuff

Intervention Type: 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.

Interventions

ViTrack

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

Intervention Type: DEVICE

Oscillometric BP Device

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dynocardia, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohan Thanikachalam, MD

Role: PRINCIPAL_INVESTIGATOR

Dynocardia, Inc

Locations

Dynocardia Inc

Newton, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mohan Thanikachalam, MD

Role: CONTACT

admin@dynocardia.care

+1 (617) 639 - 5569

Gokul Prasath Rajamanickam, MS

Role: CONTACT

gokulpr@dynocardia.care

Facility Contacts

Gokul Rajamanickam

Role: primary

gokulpr@dynocardia.care

Other Identifiers

TBPI001

Identifier Type: -

Identifier Source: org_study_id