Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Part of paid clinical trials in Newton, Massachusetts.
- Sponsor
- Dynocardia, Inc
- Study ID
- NCT04835857
- Status
- Recruiting
Conditions
- Healthy
- Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- ViTrack — DEVICEViTrack is a continuous non-invasive wearable blood pressure cuff.
- Oscillometric BP Device — DEVICEOscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.
- Auscultatory cuff — DEVICEThe 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.
Study Details
(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.
Key Dates
- Start date
- Jan 1, 2021
- Status verified
- Aug 2025
- Primary completion
- Jun 1, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 91 participants (estimated)
Arms
- Arm: Experimental-ArmFor 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
Primary Outcome Measure
Comparison of Diastolic Blood Pressure [ Time Frame: up to 30 minutes ]
Central Contacts
- Mohan Thanikachalam, MD+1 (617) 639 - 5569
- Gokul Prasath Rajamanickam, MS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dynocardia Inc | Newton | Massachusetts | 02459 | Gokul Rajamanickam |
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