Hemodynamic MonitoringNCT07862608
Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters
An observational study of Hemodynamic Monitoring, run by AcQumen Medical, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 months to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Monitoring
- What is being tested?
- Noninvasive Hemodynamic Monitoring System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2026to 27 Sep 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will enroll up to 400 volunteer participants ranging from 2 months to 95 years of age, representing a broad cross-section of the general population. Subjects must be generally healthy, as determined by verbal health history, and have had no hospitalizations or emergency care visits for cardiopulmonary conditions within the preceding 30 days. Participants may include individuals with or without stable cardiovascular or pulmonary conditions, provided they meet all inclusion criteria and have no active illness. Enrollment will include diverse racial and ethnic backgrounds and both pediatric and adult age groups. Subjects must be able to understand and comply with study procedures, and for minors, parental permission and age-appropriate assent are required. Individuals with pregnancy, lactation, active skin conditions at electrode placement sites, or known sensitivities to adhesives, hydrogel, or ultrasound gel will be excluded.
Who may be able to join
- Age 2 months to 95 years of age, of varying racial origins, and with or without cardiovascular or pulmonary disease.
- Generally healthy, as confirmed by verbal health history at screening.
- Parent or legal guardian provides written informed consent; subject provides assent where applicable and appropriate.
- Subject and parent/guardian are able to understand and comply with study procedures.
Who cannot join
- Participants who have had admission or a visit to an emergency room or hospital admission for a cardiovascular or pulmonary illness such as congestive heart failure or asthma, within the prior 30 days will be excluded.
- Females if lactating or pregnant, or if childbearing potential and without use of standard birth control, will be excluded.
- Active skin condition, injury, rash, or dermatitis in areas of planned electrode or ultrasound probe placement.
- Known latex or adhesive sensitivity or sensitivity to hydrogel or ultrasound coupling gel.
- Any condition that, in the opinion of the investigator, would compromise participant safety or the integrity of study data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
AcQumen Medical
Riverside, Connecticut, 06878
Dori Jones, MSE, 8662278636, djones@acqumenmedical.com
Jenny Freeman, MD
About this study
Official title: Evaluation of the UltraTracTM System as a Non-Invasive Monitor of Hemodyamic Parameters
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.
Read the detailed description
UltraTrac™ is a noninvasive monitoring system developed by AcQumen Medical, Inc. that combines impedance cardiography with carotid Doppler ultrasound to estimate stroke volume, cardiac output, and left ventricular ejection time continuously and without invasive procedures. Continuous hemodynamic monitoring is difficult in both pediatric and adult populations. UltraTrac uses surface-skin electrodes to calculate hemodynamics via impedance and integrates a miniature ultrasound sensor to address these limitations and is designed to function across a wide range of patient sizes, including infants, young children, and obese individuals.
This prospective, observational volunteer study is intended to collect systematic data on UltraTrac signal acquisition quality, measurement consistency, and device performance across age groups and activity conditions. Prior early data have been collected in patients under institutional IRB approval. This study expands evaluation to healthy volunteers to support device development, algorithm refinement, and future regulatory submissions, including a planned 510(k) application.
Each participant will complete a single study visit lasting approximately one hour. During the visit, study personnel place standard adhesive electrodes and a small ultrasound sensor on the skin. The device will record impedance and ultrasound signals while the participant is lying down, seated, and/or during structured movement conditions. These may include natural repositioning, passive leg raise, and simple activity such as walking in place or pedaling a small stationary bicycle. Up to ten measurement sets may be collected per condition, and ultrasound signal strength will be documented using the device's integrated signal-quality display. Some participants may return for additional visits to support intra-subject variability analysis.
The study focuses on evaluating whether UltraTrac can reliably obtain usable signals and produce consistent hemodynamic measurements under real-world conditions. Because this is an exploratory study, analyses emphasize descriptive statistics, signal-to-noise characteristics, and measurement precision. Hemodynamic values are summarized to characterize expected ranges across ages and activity states, but no clinical interpretation will be performed. UltraTrac data will not be used for diagnosis or treatment.
The device uses FDA-cleared materials, including standard monitoring electrodes and ultrasound gel. Risks are minimal and primarily related to mild skin irritation or discomfort from adhesive removal. Movement-based activities are limited to each participant's comfort level, and individuals with recent cardiopulmonary illness are excluded to reduce the risk of presyncope. No electrical current beyond standard bioimpedance monitoring levels is delivered.
Data collected from this study will help determine how well UltraTrac performs across a broad population, inform improvements to signal processing and algorithms, and support future clinical studies in acute-care environments. The long-term goal is to provide clinicians with a noninvasive, continuous tool for assessing cardiac function and detecting early hemodynamic compromise.
- Conditions
- Hemodynamic Monitoring
- Being tested
- Noninvasive Hemodynamic Monitoring System
- Keywords
- Hemodynamics, Cardiovascular Physiology, Cardiac Output, Stroke Volume, Ventricular Function, Left, Impedance Cardiography, Ultrasonography, Doppler, Monitoring, Physiologic, Volunteer, Pediatric Monitoring, Monitoring, Signal Processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Hemodynamic Monitoring SystemDevice
Also called UltraTrac, Impedance Cardiography
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Noninvasive Hemodynamic Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful waveform acquisition and adequate signal to noise characteristics
Successful ICG waveform acquisition rate as determined by counts and proportions of subjects; adequate ultrasound signal strength summarized descriptively; adequate ICG and ultrasound signal to noise characteristics summarized descriptively
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start27 Sep 2026 (estimated)
- Primary completion27 Sep 2028 (estimated)
- Study completion27 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AcQumen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862608
- Sponsor's protocol ID
- AQM-UT-001
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes