NCT07862608Not yet recruiting
Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters
Evaluation of the UltraTracTM System as a Non-Invasive Monitor of Hemodyamic Parameters
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- 27 Sept 2026
- Primary completion date
- 27 Sept 2028
- Lead sponsor
- AcQumen Medical, Inc.
- Diseases
- Stroke
- NCT number
- NCT07862608
What you commit to
- Study type: Observational
- Planned participants: 400
- From 27 Sept 2026 to the primary completion date, 27 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Active skin condition, injury, rash, or dermatitis in areas of planned electrode or ultrasound probe placement.
- Any condition that, in the opinion of the investigator, would compromise participant safety or the integrity of study data.
Other
- Females if lactating or pregnant, or if childbearing potential and without use of standard birth control, will be excluded.
- Known latex or adhesive sensitivity or sensitivity to hydrogel or ultrasound coupling gel.
Who the study is looking for
- 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.
Age in the registry: 2 months to 95 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AcQumen Medical Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.