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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835857
• Other study ID #: TBPI001
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2023
• Source: Dynocardia, Inc
• Contact: Mohan Thanikachalam, MD
• Phone: +1 (617) 639 - 5569
• Email: admin[@]dynocardia.care
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: November 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Dynocardia Inc	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dynocardia, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Diastolic Blood Pressure	3 sets readings compared across blood pressure (mmHg)	up to 30 minutes
Primary	Comparison of Systolic Blood Pressure	3 sets readings compared across blood pressure (mmHg)	up to 30 minutes
Secondary	Skin Irritation	Examining for local skin irritation	Up to 72 hours