Testing a skin-sensor device that measures heart function without needles in healthy volunteers
Tests the UltraTrac device for measuring heart function without needles in healthy volunteers.
Plain-language title generated from the registry record
Registry title: Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters
Key facts
- Where
- Riverside, United StatesSee the site
Where in United States
- AcQumen MedicalRiverside, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AcQumen Medical, Inc.
- Trial code
- NCT07862608
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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.