Comparing a new wrist blood pressure device to traditional cuff-based 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
This study is testing a new wrist blood pressure device called ViTrack to see if it gives accurate readings compared to traditional cuff-based devices in healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 91 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Dynocardia, Inc Industry-sponsored |
| Locations | 1 site (Newton, Massachusetts) |
| Trial ID | NCT04835857 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the accuracy of a cuff-less wrist wearable device called ViTrack in measuring blood pressure compared to traditional cuff-based devices. Healthy volunteers, both male and female, aged 18 and above, will participate in the study. The ViTrack device will be strapped over the radial artery at the wrist, and its readings will be compared with those obtained from a standard cuff-based blood pressure measuring device on the same arm. The goal is to determine if the new device can provide reliable blood pressure measurements.
Who should consider this trial
Good fit: Ideal candidates are healthy volunteers aged 18 and older, with normal or high blood pressure.
Not a fit: Patients with conditions affecting wrist function or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to more convenient and accurate blood pressure monitoring for patients.
How similar studies have performed: While there have been studies on wearable blood pressure devices, the specific comparison of the ViTrack to traditional methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Newton, Massachusetts
- Dynocardia Inc — Newton, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mohan Thanikachalam, MD — Dynocardia, Inc
- Study coordinator: Mohan Thanikachalam, MD
- Email: admin@dynocardia.care
- Phone: +1 (617) 639 - 5569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.