Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05909605

Enrollment

150

Registered

2023-06-18

Start date

2020-10-20

Completion date

2023-12-02

Last updated

2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feasibility Study, Medical Device

Brief summary

Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor oﬀers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.

Interventions

DEVICEsphygmomanometer

Comparison to the ultrasound sensor

DEVICEArterial Line

Comparison to the ultrasound sensor

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* Are able to provide informed consent * Have at least one arm

Exclusion criteria

* Active cardiac arrhythmias * Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure) * Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential) * Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff * Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure * Diagnosis of dementia

Design outcomes

Primary

Measure	Time frame	Description
Device comparison to standard monitoring (Sphygmomanometer)	2 years	Clinical feasibility of the calibration accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 10 participants.
Device comparison to standard monitoring (A-line)	2 years	Clinical feasibility of the ultrasound blood pressure sensor for monitoring trend changes for continuous 12 hours of measurement in comparison to an arterial line in the Intensive Care Unit on 10 participants.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026