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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

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-Arm
    For 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

Locations (1)

FacilityCityStateZIPSite coordinators
Dynocardia IncNewtonMassachusetts02459
Gokul Rajamanickam

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