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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "(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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares ViTrack, a wrist-worn blood pressure device with no cuff, to a standard blood pressure device with a cuff. It is for healthy volunteers age 18 or older 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a healthy volunteer age 18 or older with a normal heart rhythm.
  • The study seeks equal numbers of males and females.
  • Agree to take part and follow the study plan.
  • Be able to understand the consent form and other required documents, and sign the consent form before any study procedures.

Who can't join

  • Cannot or do not want to give consent.
  • Have any condition that the study doctor thinks would make taking part more risky.
  • Have a difference of more than 10 mm Hg in the top blood pressure number between arms when measured with a cuff.
  • Have a surgically made link between an artery and a vein in an arm for dialysis, a treatment that filters blood.
  • Have a wrist that is misshapen or painful because of arthritis.
  • Have had an injury or surgery where the device will check the artery at the wrist.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA