Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters

Conditions

• Hemodynamic Monitoring

Eligibility Criteria

Sex

ALL

Age

2 Months - 95 Years

Healthy Volunteers

Accepted

Interventions

• Noninvasive Hemodynamic Monitoring System — DEVICE
  This study involves the use of a noninvasive hemodynamic monitoring system that integrates impedance cardiography with Doppler ultrasound to measure cardiac function. The system uses standard adhesive electrodes placed on the skin and a small ultrasound sensor positioned over the carotid or femoral artery. During each measurement period, the system collects impedance waveforms and ultrasound timing signals to estimate stroke volume, cardiac output, and left ventricular ejection time. Data are recorded while participants are at rest and during simple movement conditions to evaluate signal acquisition quality, measurement precision, and device performance. The UltraTrac is used only for physiologic monitoring and data collection. Study data are not used to deliver therapy, influence clinical care, or provide diagnostic information to participants or clinicians.

Study Details

This study will test the use of the UltraTrac™ system, a small, noninvasive device that uses electrodes on the skin and a small ultrasound sensor to provide measurements of cardiac function in a wide of subjects. UltraTrac estimates cardiac output and other hemodynamic parameters without needles or invasive procedures. Up to 400 generally healthy volunteers, from infants to older adults, will take part in a single study visit lasting about one hour. During the visit, study staff place small adhesive electrodes on the skin and a lightweight ultrasound sensor on the neck or thigh. The device records heart-related signals while the participant is lying down, sitting, and during simple movements such as repositioning, passive leg raise, or light exercise (like walking or pedaling in place). The study evaluates how often the UltraTrac device can collect good-quality signals and how consistent the measurements are across different ages and activity levels. There is no direct medical benefit to participants. The risks are minimal, such as mild skin irritation from adhesive electrodes. The information collected will help improve the UltraTrac system and support future regulatory review so that noninvasive cardiac monitoring may become more widely available, especially for children and other patients who are not able to undergo invasive monitoring.

Key Dates

First listed

Oct 7, 2026

Start date

Sep 27, 2026

Status verified

Oct 2026

Primary completion

Sep 27, 2028

Completion

Sep 27, 2028

Study Design

Enrollment

400 participants (estimated)

Arms

• Arm: Healthy Volunteer Cohort
  This cohort includes generally healthy volunteer participants ranging from infants to older adults who complete a single study visit involving noninvasive monitoring with the UltraTrac™ system. All participants undergo a structured measurement protocol, which includes placement of standard adhesive electrodes and a small Doppler ultrasound sensor, followed by resting, and for some participants, movement-based measurement conditions. UltraTrac collects impedance and ultrasound signals to evaluate device performance, signal acquisition quality, and measurement consistency. No clinical interventions are performed, and device output is used solely for research and development purposes.

Primary Outcome Measure

Rate of successful waveform acquisition and adequate signal to noise characteristics [ Time Frame: Baseline ]

Locations (1)

Find similar trials in Riverside, CT

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