Status:
RECRUITING
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Lead Sponsor:
Dynocardia, Inc
Conditions:
Hypertension
Healthy
Eligibility:
All Genders
18-90 years
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 ...
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 pres...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04835857
Start Date
January 1 2021
End Date
November 30 2026
Last Update
September 5 2025
Active Locations (1)
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1
Dynocardia Inc
Newton, Massachusetts, United States, 02459