[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AcQumen Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100659540","ultratrac-clinical-pilot-study-100659540",false,"NCT07864714","UltraTrac Clinical Pilot Study","Clinical Pilot Study of UltraTrac-determined Cardiac Output With Standard Measures of Cardiac Output","ULTRA-CO","Inclusion Criteria:\n\n1. Provision of signed and dated parental permission form (for patients \\\u003C18) or informed consent form (for patients \\>= 18 years)\n2. Provision of verbal (for patients 7-11) or signed and dated assent form (for patients 12-17)\n3. Stated willingness to comply with all study procedures\n4. Male or female, aged 0 - 21 years\n5. Scheduled to undergo standard of care diagnostic cardiac catheterization at Children's National Hospital\n\nExclusion Criteria:\n\n1. Weight less than 2.5kg\n2. Patients who are hemodynamically unstable, as assessed by the attending physician\n3. Broken skin or poor skin integrity that would prohibit safe adhesion of electrodes or Doppler probe\n4. Known moderate-to-severe reactions to electrocardiogram electrode adhesives or ultrasound gel","ALL","0 Years","21 Years",{"count":21,"type":22},50,"ESTIMATED","OBSERVATIONAL","This single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac catheterization. UltraTrac integrates ultrasound with impedance cardiography (ICG) to refine stroke volume and cardiac output calculations. During catheterization, trained staff will apply four surface-skin electrodes and a Doppler probe and obtain UltraTrac measurements without altering standard clinical care. The primary objective is to assess concordance between algorithm-derived cardiac output and gold-standard invasive measurements (Fick or thermodilution). The secondary objective is to evaluate human-factors issues reported by clinicians during device use. The study will enroll 50 hemodynamically stable pediatric participants, with up to 60 screened to account for screen failures. UltraTrac poses no more than minimal risk, using noninvasive sensors comparable to standard electrocardiogram (ECG) and Doppler procedures. Measurements will be performed only when clinically appropriate, and no UltraTrac data will be used to guide patient care.",[26],"Hemodynamic Monitoring",[28,29,30,31,32,33,34,35],"hemodynamics","Cardiovascular Physiology","Cardiac Output","Stroke Volume","Impedance Cardiography","Pediatric Monitoring","Ultrasonography, Doppler","Signal Processing","NOT_YET_RECRUITING","2026-10-02",{"date":39,"type":40},"2026-10-08","ACTUAL",{"date":42,"type":22},"2026-10",{"date":44,"type":22},"2027-10",{"name":46,"class":47},"AcQumen Medical, Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100659408","evaluation-of-the-ultratrac-system-as-a-non-invasive-monitor-of-hemodynamic-parameters-100659408","NCT07862608","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","Inclusion Criteria:\n\n1. Age 2 months to 95 years of age, of varying racial origins, and with or without cardiovascular or pulmonary disease.\n2. Generally healthy, as confirmed by verbal health history at screening.\n3. Parent or legal guardian provides written informed consent; subject provides assent where applicable and appropriate.\n4. Subject and parent\u002Fguardian are able to understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. 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.\n2. Females if lactating or pregnant, or if childbearing potential and without use of standard birth control, will be excluded.\n3. Active skin condition, injury, rash, or dermatitis in areas of planned electrode or ultrasound probe placement.\n4. Known latex or adhesive sensitivity or sensitivity to hydrogel or ultrasound coupling gel.\n5. Any condition that, in the opinion of the investigator, would compromise participant safety or the integrity of study data.",true,"2 Months","95 Years",{"count":60,"type":22},400,"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.\n\nUp 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.\n\nThere 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.",[26],[64,29,30,31,65,32,34,66,67,33,68,35],"Hemodynamics","Ventricular Function, Left","Monitoring, Physiologic","Volunteer","Monitoring","2026-10-01",{"date":71,"type":40},"2026-10-07",{"date":73,"type":22},"2026-09-27",{"date":75,"type":22},"2028-09-27",{"name":46,"class":47},""]