[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GE Healthcare\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":368},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,55,78,108,129,164,184,205,231,252,276,297,318,341],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053942","nibp-accuracy-study-for-adult-subject-populations-100053942",false,"NCT07697950","NIBP Accuracy Study for Adult Subject Populations","Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations","Inclusion Criteria:\n\n1. Age requirement: 18 and over.\n2. Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).\n3. Have an arterial line as a standard of care, which measures blood pressure at the aortic root.\n4. Able to provide written informed consent.\n5. Expected to remain in the unit for the duration of the study procedure.\n\nExclusion Criteria:\n\n1. Have previously participated in this study (no subject may participate more than once).\n2. Pregnant and lactating women per site standard of care.\n3. Subjects with peripheral arterial diseases (causing left\u002Fright arm difference)\n4. Hemodynamically unstable subjects at the discretion of the investigator.\n5. Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.\n6. Are suffering from infection(s) or immunocompromised patients that require isolation.\n7. PI or designee decision due to subject health conditions","ALL","18 Years",{"count":19,"type":20},130,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.",[26,27],"Blood Pressure Measurement","Blood Pressure","RECRUITING","2026-07-07",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2025-01-13",{"date":36,"type":20},"2027-12-31",{"name":38,"class":39},"GE Healthcare","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":46,"briefSummary":24,"conditions":47,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":54,"locationsCount":40},"100643127","non-invasive-blood-pressure-accuracy-study-for-adult-subject-populations-100643127","NCT07628296",{"count":19,"type":20},[23],[27,26],"2026-06-29",{"date":50,"type":32},"2026-07-01",{"date":34,"type":32},{"date":53,"type":20},"2027-06-30",{"name":38,"class":39},{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":40},"100638570","spo2-infant-and-pediatric-study-100638570","NCT07615738","SpO2 Infant and Pediatric Study","Assessment of TruSignal SpO2 Form, Fit and Clinical Performance With Infant and Child Patients","SpO2 Peds","Inclusion Criteria:\n\n* subjects are 1-23 months (infant cohort) or 2-12 years old (child cohort)\n* requiring arterial blood samples per the site's standard of care.\n\nExclusion Criteria:\n\n* Fractional Methemoglobinemia (FMetHb \\>2%) or Fractional carboxyhemoglobinemia (FCOHb \\>3%), within 24 hours of arterial blood draw.\n* Severe anemia (tHb \\\u003C7g\u002FdL) within 4 hours prior to arterial blood gas draw.\n* Hematocrit (Hct) \\\u003C25 within 4 hours prior to arterial blood gas draw.\n* Patients with injuries, deformities, or abnormalities which may prevent proper application of the sensor.\n* Patients on Extracorporeal Membrane Oxygenation (ECMO).\n* Patients receiving point of care (POC) testing for blood gases.\n* Patients with diseases\u002Fconditions that may cause differential (or reverse differential) cyanosis including, but not limited to:\n* Patent ductus arteriosus with pulmonary arterial hypertension.\n* Pulmonary hypertension and left-heart abnormalities aortic arch hypoplasia, interrupted aortic arch, critical coarctation, and critical aortic stenosis.\n* Children with transposition of the great arteries (TGA) and coarctation of the aorta or interrupted aortic arch, and TGA with suprasystemic pulmonary vascular resistance.\n* At the discretion of the principal investigator or designee due to the subject health condition.","29 Days","12 Years",{"count":66,"type":20},180,[23],"This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years). It compares SpO₂ measurements from the device to arterial oxygen saturation (SaO₂) values from arterial CO-oximetry, and assesses the reliability of usable data, performance across skin tones, and user feedback.",[70,71],"SpO2 (Peripheral Oxygen Saturation) Measurement Validation","SpO2","NOT_YET_RECRUITING",{"date":50,"type":32},{"date":75,"type":20},"2026-06-15",{"date":36,"type":20},{"name":38,"class":39},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100629270","phase-2-a-phase-23-study-on-the-efficacy-and-safety-of-mangaciclanol-for-contrast-enhanced-mri-of-cns-or-body-in-adult-patients-100629270","NCT07472491","A Phase 2\u002F3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients","A Prospective, Multicenter Phase 2\u002F3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)","LUMINA","Inclusion Criteria:\n\n* The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF.\n* The participant is able and willing to comply with study procedures as described in the protocol.\n* The participant has read, understood, signed and dated the ICF prior to any study procedures.\n* Phases 2 and 3 CNS: Participants presenting with known or highly suspected enhancing CNS lesions referred as part of standard care for contrast-enhancing MRI of the CNS. The suspicion may be based on a previous imaging procedure such as computed tomography (CT), positron emission tomography (PET)\u002FCT or MRI performed within 12 months prior to ICF signature.\n* Phase 3 body only: Participants presenting with known or highly suspected enhancing lesions in at least 1 body region (i.e., head and neck, thorax, abdomen, pelvis, and musculoskeletal system \\[only breast in the United States in compliance with local approved indications of gadobutrol\\]) referred as part of standard care for contrast-enhancing MRI of the body. The suspicion may be based on a previous imaging procedure such as CT, PET\u002FCT, ultrasound or MRI performed within 12 months prior to ICF signature.\n* The participant is scheduled for a contrast-enhanced MRI examination of the CNS or a body region for clinical reasons and has agreed to have a second contrast-enhanced MRI examination for the purpose of this study.\n* The participant is in a clinically stable condition (i.e., no acute deterioration within 48 hours before enrollment).\n* Female Participants: The participant is a female who is either surgically sterile (has had a documented bilateral oophorectomy, bilateral salpingectomy, and\u002For documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum human chorionic gonadotropin pregnancy test, performed at screening and the results of a urine pregnancy test, or serum human chorionic gonadotropin pregnancy test performed prior to each administration of IMP (with the result known before IMP administration), must be negative. Female participants of childbearing potential must agree to use adequate contraception and not harvest or donate eggs from screening until 30 days after final dose of IMP. Such methods include hormonal contraception including oral, intravaginal, transdermal, injectable, and implantable contraceptives; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner. Total abstinence, in accordance with the lifestyle of the participant, is also acceptable.\n* Male Participants: The participant is a male who is surgically sterile (vasectomy or bilateral orchidectomy), a male who is sexually active with a partner who is not of childbearing potential, or a male who is sexually active with a partner of childbearing potential who must agree to use adequate contraception and not harvest or donate sperm from screening until 90 days after final dose of IMP. Adequate contraception for the male participant (and any female partner, if she is of childbearing potential) is defined as using hormonal contraception (including oral, intravaginal, transdermal, injectable or implantable contraceptives), an intrauterine device, or an intrauterine hormone-releasing system, combined with at least one of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the participant, is also acceptable.\n\nExclusion Criteria:\n\n* The participant has previously enrolled in this mangaciclanol study, including participation in an earlier phase or cohort.\n* The participant has a contraindication to MRI examination, such as the presence of a cardiac pacemaker or other electronic devices, presence of ferromagnetic metal foreign bodies in vulnerable positions or within positions that would affect the imaged field of view, presence of certain tattoos that may raise a safety concern for MRI, participant suffering from severe claustrophobia which is not manageable with standard sedation, or participant working as a machinist, welder or metal worker (unless the participant will undergo thorough screening by radiology personnel to rule out the presence of metallic foreign bodies, especially in or near the eyes).\n* Participant with severe cardiovascular disease (e.g., known long QT syndrome including QTc prolongation based on screening ECG, acute myocardial infarction within the past 14 days, unstable angina, congestive heart failure class III\u002FIV by New York Heart Association classification, or acute stroke within the past 48 hours).\n* (Phase 2 only) Participant with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) within 14 days prior to the first IMP administration.\n* (Phase 3 only) Participant with an eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 calculated using the CKD-EPI within 14 days prior to the first IMP administration.\n* Participant with increased likelihood of hypersensitivity specifically to mangaciclanol, gadolinium or a component of the formulation.\n* Participant has received any non-study contrast agent within 72 hours prior to the first study MRI, or is planning to receive any non-study contrast agent during the trial until 24 ± 4 hours after the second study MRI.\n* Participant has received any investigational product within 30 days or within 5 times the half-life of that drug, whichever is shorter, prior to or concurrent with this study.\n* Participant is expected\u002Fscheduled to have any treatment or medical procedure (e.g., chemotherapy, radiotherapy, biopsy, resection, etc.) that may impact aspects of the imaged lesions from the first study MRI up to 24 hours after the second study MRI. (Participants under corticosteroids and\u002For maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).\n* Participant may not be able to complete the study, based on their anticipated life expectancy, or where study participation may compromise the management of the participant, or any other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study.\n* Participant is pregnant or planning to become pregnant, or breast-feeding.\n* Participant is unable or unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and\u002For considered unlikely to complete the trial.",{"count":87,"type":20},640,[89,90],"PHASE2","PHASE3","This is an operationally combined Phase 2\u002F3 study, which will be conducted and evaluated in 2 distinct parts:\n\n* Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.\n* Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body.\n\nThe investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).\n\nPrimary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.",[93,94],"Known or Highly Suspected Central Nervous System (CNS) Lesion","Known or Highly Suspected Body (Excluding CNS) Lesion",[96,97,98,99],"Contrast-enhanced magnetic resonance imaging (MRI)","Mn-based contrast agents (MBCAs)","Gd-based contrast agents (GBCAs)","Lesion visualization","2026-06-26",{"date":48,"type":32},{"date":103,"type":32},"2026-04-01",{"date":105,"type":20},"2027-11-30",{"name":38,"class":39},7,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100641556","data-collection-of-new-spectral-ct-imaging-method-100641556","NCT07661706","Data Collection of New Spectral CT Imaging Method","Inclusion Criteria:\n\n* Who are ≥18 years of age;\n* Able to sign and date the informed consent form; AND,\n* Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.\n\nExclusion Criteria:\n\n* Who are pregnant or lactating;\n* Who were previously enrolled in this study;\n* For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;\n* For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;\n* Who need urgent or emergent care;\n* Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR,\n* Who are unwilling to have GEHC personnel present for the CT exam.",true,{"count":116,"type":20},50,"OBSERVATIONAL","The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.",[120],"Computed Tomography","2026-06-16",{"date":123,"type":32},"2026-06-22",{"date":125,"type":32},"2025-12-19",{"date":127,"type":20},"2026-08",{"name":38,"class":39},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":145,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100609796","phase-2-study-to-evaluate-the-diagnostic-performance-of-geh300079-68ga-injection-petct-for-detection-of-pc-in-patients-with-colorectal-gastric-ovarian-or-pancreatic-cancers-periscope-100609796","NCT07219238","Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET\u002FCT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)","A Phase 2\u002F3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)\u002FComputed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)","Inclusion Criteria:\n\n* Participant is ≥18 years of age\n* Participant has provided signed informed consent before any study-specific screening procedures\n* Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC\n* Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.\n* Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET\u002FCT Imaging Visit\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Participant is able and willing to comply with all study procedures as described in the protocol\n\nExclusion Criteria:\n\n* Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP)\n* Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures\n* Participant needs any intervention that would delay study participation\n* Participant has non-resectable extra-abdominal metastasis and\u002For \\>3 hepatic metastases on standard work up\n* Participant will not be able to complete the study, based on their anticipated life expectancy\n* Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)\n* Participant has renal function impairment as defined by:\n\n  1. For Phase 2: estimated glomerular filtration rate less than 60 mL\u002Fmin\n  2. For Phase 3: estimated glomerular filtration rate less than 30 mL\u002Fmin\n* Participant has severe hepatic function impairment as defined by:\n\n  1. Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) and alanine aminotransferase (serum glutamic-pyruvic transaminase): ≤2.5 × upper limit of normal (ULN; ≤5 × ULN for participants with liver metastases)\n  2. Bilirubin: ≤1.5 × ULN or direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n* Participant has autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and\u002For protocol objectives\n* Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)\n* Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)\n* Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET\u002FCT scan for any reason\n* (Phase 3 only) Participant was previously included in Phase 2 of this study",{"count":137,"type":20},175,[89,90],"This study is a Phase 2\u002F3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET\u002FCT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET\u002FCT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study.\n\nThe study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET\u002FCT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET\u002FCT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.",[141,142,143,144],"Colorectal Cancer","Gastric Cancers","Ovarian Cancers","Pancreatic Ductal Adenocarcinoma",[146,147,148,149,150,151,152,153,154,155],"Peritoneal Carcinomatosis (PC)","Pancreatic Cancers","Colorectal cancer","Gastric cancer","FAPI","Ovarian cancer","68Ga","PET\u002FCT imaging","Diagnostic imaging","Diagnostic performance",{"date":157,"type":32},"2026-06-17",{"date":159,"type":20},"2026-10",{"date":161,"type":20},"2029-08",{"name":38,"class":39},2,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":40},"100616761","portrait-mobile-monitoring-solution-v20-external-evaluation-100616761","NCT07309809","Portrait Mobile Monitoring Solution V2.0 External Evaluation","Inclusion Criteria:\n\n1. Participant is age 18 years or older (≥18 years).\n2. Participant must have the ability to understand and provide written informed consent.\n3. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure.\n4. Participant must be willing and able to comply with study procedures and duration.\n\nExclusion Criteria:\n\n1. Known to be pregnant and\u002For breast feeding.\n2. Diagnosed with infection requiring isolation.\n3. Are immunocompromised.\n4. Have previously participated in this study (no subject may participate more than once).\n5. Subjects with Implantable Minute Ventilation Rate Responsive Pacemakers should be excluded from respiration rate monitoring.",{"count":116,"type":20},[23],"The purpose of this study is to collect and assess feedback from the users regarding the functionality and performance of the Portrait Mobile Monitoring Solution V2.0. In addition, this study aims to collect raw parameter data from the investigational devices for use in current and future Portrait Mobile development, including engineering purposes as deemed appropriate by the Sponsor.",[174],"Monitoring",[176],"Continuous Monitoring","2026-06-08",{"date":179,"type":32},"2026-06-10",{"date":181,"type":20},"2026-07",{"date":159,"type":20},{"name":38,"class":39},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":40},"100623246","nmt-easyfit-sensor-and-cable-100623246","NCT07394140","NMT EasyFit Sensor and Cable","Evaluate Functionality and Use of the NMT EasyFit Sensor and NMT EasyFit Cable","Inclusion Criteria:\n\n1. Study subject (male or female) is age 18 years or older (≥18 years).\n2. Study subject must have the ability to understand and provide written informed consent.\n3. Study subject is undergoing a clinically indicated procedure requiring the use of paralytic medication.\n4. Study subject will have the primary NMT monitoring conducted using an NMT ElectroSensor on the hand\u002Fforearm.\n\nExclusion Criteria:\n\n1. Are known to be pregnant.\n2. Are breastfeeding.\n3. Suffering from an infection(s) that requires isolation.\n4. Deformity, scar tissue, tattoos, or other characteristics at the sensor application area that could interfere (e.g., nerve damage) with the completion of the study procedure or identify a study subject.\n5. Subjects requiring rapid sequence induction\n6. Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study.\n7. Direct employees or contractors of GE HealthCare, or any company that makes NMT monitoring devices (sensors, cables, modules).\n8. NMT ElectroSensor placed on the foot\u002Fankle",{"count":192,"type":20},30,[23],"The purpose of this clinical study is to collect and assess feedback from clinical users regarding the functionality and device use and collection of raw parameter date from the NMT Sensor and NMT Cable.",[196,197],"Neuromuscular Blockade Monitoring","NMT","2026-05-28",{"date":200,"type":32},"2026-06-01",{"date":75,"type":20},{"date":203,"type":20},"2026-12-31",{"name":38,"class":39},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":213,"maxAge":17,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100408923","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-regadenoson-in-pediatric-patients-100408923","NCT04604782","A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients","An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Pediatric Patients","Rapiscan PIP","Inclusion Criteria:\n\n* \\* Male or female adolescent aged from 12 to \\\u003C18 years (Cohort A) or child aged from 2 to \\\u003C12 years (Cohort B) or infant aged from 1 to \\\u003C24 months (Cohort C).\n\n  * Patient weighs at least 3 kg.\n  * Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacologic stress perfusion CMR may be performed in patients for further evaluation of cardiovascular conditions or diseases, such as, but not limited to, Kawasaki disease, congenital heart diseases, congenital coronary abnormalities, and post-cardiac surgery \u002F transplantation, etc.\n  * Stable medication regimen for at least 7 days prior to dosing. Stable is defined as no addition, discontinuation, or change of any medications (or their doses), that could alter the rate-pressure product (HR x BP).\n  * Patients and those whose parents or legally authorised representatives are, in the Investigator's view, likely to be compliant and complete the study will be eligible to participate\n  * Post-menarchal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day.\n  * Post-menarchal female patients must be practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study\n\nExclusion Criteria:\n\n* \\* Prior allergic reaction to Gd contrast agents and\u002For regadenoson or any component of its formulation, or to aminophylline or to its components (ethylenediamine and theophylline).\n\n  * Standard clinical contraindications to MRI as per institutional guidance, including patients with cochlear implants and implanted cardiac devices, or considered unfit for a pharmacologic stress perfusion CMR test by the investigator.\n  * All patients will be screened for eGFR within 24 hours before the exam and patients presenting with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (by the Schwartz formula) will be excluded.\n  * Pregnant or lactating females, or females of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test also required).\n  * In the judgment of the Investigator, any clinically significant ongoing medical condition (e.g., myocardial infarction, or unstable angina within 5 days, pericardial inflammatory disease, severe cardiac outflow tract obstruction, acutely decompensated heart failure, uncontrolled epilepsy, high risk for seizures, etc.) or clinically significant laboratory abnormality that is considered to potentially jeopardise the patient's safety.\n  * Patients with 2nd or 3rd degree atrioventricular block or sick sinus syndrome with or without an artificial pacemaker.\n  * Known or suspected bronchoconstrictive and bronchospastic lung disease either being unstable or requiring active treatment (e.g., wheezing noted on physical exam, frequent exacerbations or active treatment with a bronchodilator or corticosteroids).\n  * Out of acceptable range sitting or semi-recumbent resting BP or HR (beats per minute \\[bpm\\]) at screening as provided below:\n\n    1. Acceptable range for BP (systolic \u002F diastolic mmHg):\n* For Cohorts A and B: 85-130 \u002F 45-90\n* For Cohort C: 80-120 \u002F 40-80 b) Acceptable range for HR:\n* For Cohort A: 55 to 100 bpm\n* For Cohort B: 60 to 120 bpm\n* For Cohort C: 70 to 160 bpm\n\n  * Use of any experimental or investigational drug or device within 30 days prior to dosing with study drug\n  * Consumption of methylxanthine-containing products such as caffeinated coffee, tea, caffeinated soft drinks, cocoa or chocolate in the 48 hours prior to dosing\n  * Aminophylline or theophylline use within 24 hours, dipyridamole use within 48 hours prior to dosing.\n  * History of alcohol abuse or drug addiction, as determined by the Investigator\n  * Currently smokes more than 5 cigarettes or equivalent per day, and if eligible for the study, would not be able to abstain from smoking from midnight prior to dosing until the end of the study period\n  * Positive urine drug screen at the screening visit, including amphetamines, barbiturates, cannabinoids, cocaine, ethanol and opiates. This will be performed for all patients in Cohort A and those patients at age-appropriate risk in Cohorts B and C, as determined by the investigator.\n\nNote: If the patient is currently receiving prescribed medications containing any of these ingredients, re-screening can only be considered if found acceptable based on the best medical judgement of the investigator and after discussion with the medical monitor. Otherwise, patients with a positive urine drug test will be considered a screen failure.","4 Weeks",{"count":215,"type":20},54,[217,89],"PHASE1","This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 paediatric age groups for whom a pharmacologic stress perfusion CMR test is clinically indicated; adolescents aged 12 to \\\u003C18 years (Cohort A), children aged 2 to \\\u003C12 years (Cohort B), and infants aged 1 to \\\u003C24 months and who weigh at least 3 kg (Cohort C). Regadenoson will be used as the pharmacologic stress agent in this study with MPI serving as both surrogate pharmacodynamic marker of the agent (MPR, MBF) and a clinically evaluable examination for the patient",[220,221],"Myocardial Ischemia","Coronary Artery Disease","2026-04-30",{"date":224,"type":32},"2026-05-06",{"date":226,"type":32},"2021-05-20",{"date":228,"type":20},"2026-12",{"name":38,"class":39},5,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":40},"100570105","gsi-cardiac-on-revolution-apex---us-100570105","NCT06702917","GSI Cardiac on Revolution Apex - US","Wide Coverage GSI Cardiac Data Collection","Inclusion Criteria:\n\nSubjects may be included in this study if they meet the following criteria:\n\n1. Who are ≥18 years of age;\n2. Able to sign and date the informed consent form; AND,\n3. Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,\n4. Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.\n\nExclusion Criteria:\n\nSubjects may be excluded from participating in study if they meet any of the following criteria:\n\n1. Who are pregnant or lactating;\n2. Who were previously enrolled in this study;\n3. Anyone with known or suspected allergy to iodinated contrast agents;\n4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;\n5. Who are in need of urgent or emergent care;\n6. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject;\n7. Who are unwilling to have GEHC personnel present for the CT exam; AND,\n8. Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)",{"count":116,"type":20},"The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system.\n\nTwo groups of participants will be enrolled:\n\nA) Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care\n\nB) Participants scheduled to undergo a cardiac catheterization or have a history of heart attack\n\nParticipants in Group A will:\n\n-Have a standard of care CCTA immediately followed by a research GSI Cardiac scan\n\nParticipants in Group B will:\n\n-Have a research CCTA immediately followed by a research GSI Cardiac scan\n\nBoth groups will be in the study for approximately 1 day. There are no follow-up visits after the day of scan.",[241,242,243],"Coronary Computed Tomographic Angiography","Myocardial Infarction (MI)","Cardiac Catheterization","2026-04-24",{"date":246,"type":32},"2026-04-27",{"date":248,"type":32},"2025-09-10",{"date":250,"type":20},"2026-06",{"name":38,"class":39},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100565257","phase-4-phase-4-paediatric-study-to-evaluate-sonazoid-safety-and-efficacy-for-contrast-enhanced-ultrasound-liver-imaging-100565257","NCT06639828","Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging","A Phase 4, Open-Label, Non-randomised, Multicentre Study to Evaluate Safety and Efficacy of Intravenous Administration of Sonazoid™ for Contrast-Enhanced Ultrasound Liver Imaging in Paediatric Patients","Inclusion Criteria:\n\n* The subject is \\\u003C18 years of age on the day of consent.\n* The subject has at least 1 untreated FLL with ≤8 lesions (excluding cysts), with ≤8 cm confirmed in a diagnostic examination performed in the past month (or past 3 months if the lesion was benign) and that could also be visualised when obtained via unenhanced ultrasound imaging\n* The subject has had a dynamic CECT or CEMRI examination within the past month or is scheduled to have one in the month following inclusion in the study, and these images are\u002Fwould be available.\n* The subject can comply with study procedures.\n* Parents or legally authorised representatives have signed the Informed Consent Form approved for this study by the Independent Review Board (IRB)\u002FIndependent Ethics Committee (IEC). The form will indicate that the patient (and\u002For a legally acceptable representative) has been informed of all pertinent aspects of the study. Patients who are able to provide assent have signed an age-appropriate paediatric assent form\n* Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day.\n* Post-menarcheal female patients and male patients who are sexually active with a partner of childbearing potential must be practicing abstinence or be using an effective form of birth control (See Section 8.6) for ≥30 days before being enrolled in the study\n* The subject has a body weight of 3 kg or greater.\n* The subject has a negative egg allergy test if the egg allergy status of the subject is unknown.\n\nExclusion Criteria:\n\n* The subject has a known or suspected hypersensitivity to any of the components of Sonazoid™, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension, or shock).\n* The subject has an acute clinically fatal condition (i.e., the expected survival is ≤6 months).\n* The subject has previously received Sonazoid™ or another ultrasound contrast agent within the past 30 days.\n* The subject had undergone or is planning to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, MRI contrast agent or another ultrasound contrast agent) within the 24 hours before or after Sonazoid™ injection.\n* The subject has undergone or was undergoing systemic or loco-regional chemotherapy or radiation therapy\n* The subject is participating in another clinical trial with an unregistered medicinal product, or less than 30 days has passed since the subject completed participation in such a trial\n* The subject is a pregnant or lactating female.\n* The physician judges that a large-enough needle (24-gauge or larger) cannot be inserted.\n* The subject has a known right-left cardiac shunt.",{"count":116,"type":20},[261],"PHASE4","Liver tumours, 40% of which are benign, account for 1% to 4% of all solid tumours in children. The benign tumours are mainly haemangiomas, liver hamartomas, and liver cell adenomas. The malignant tumours are mainly hepatoblastoma, hepatocellular carcinoma (HCC), malignant liver mesothelioma, and rhabdomyosarcoma. The differential diagnosis of liver masses in children is generally based on the child's age, the clinical evaluation (including alpha-fetoprotein test results), and imaging characteristics.\n\nLiver tumours seldom produce clear symptoms and signs in the early stages, and they progress rapidly. As a result, most liver tumours are not diagnosed until the middle or late stages. To improve survival among patients with liver tumours, clinicians must find the liver tumours as early as possible and determine whether the tumours are benign or malignant. Conventional ultrasonography is commonly used for screening, and is preferred as the first-line imaging technique for children. Not only does it have a wide range of applications and a high diagnostic yield, but it is well accepted by patients and their parents. It can be performed in the examination room with the parents present, allowing real-time imaging and direct interaction with patient and parents.\n\nCEUS is a non-invasive imaging technology that can continuously and dynamically observe blood perfusion in tumours in real-time through injection of a contrast agent to enhance the blood flow reflux signal in the human body. Consequently, CEUS is useful for visualising capillaries and tissue perfusion in the human body.\n\nThe purpose of this current study is to evaluate the use of Sonazoid™ perfluorobutane (PFB) microbubbles as a contrast medium for CEUS for evaluation of solitary liver masses in children.",[264],"Focal Liver Lesions",[266],"Contrast-Enhanced Ultrasound","2026-03-03",{"date":269,"type":32},"2026-03-04",{"date":271,"type":32},"2025-01-20",{"date":273,"type":20},"2026-10-31",{"name":38,"class":39},6,{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":163},"100487638","phase-1-a-study-to-evaluate-geh200520geh200521-18f-safety-and-tolerability-when-used-for-pet-scans-in-patients-with-solid-tumour-malignancies-100487638","NCT05629689","A Study to Evaluate GEH200520\u002FGEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies","A Phase 1a\u002F1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients With Solid Tumour Malignancies to Evaluate GEH200520 Injection \u002F GEH200521 (18F) Injection Safety and Tolerability, PET Imaging, Pharmacokinetics, and Changes in Imaging After Treatment","Inclusion Criteria:\n\n* The subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed.\n* The subject is male or female, ≥18 years of age.\n* Subject has a life expectancy ≥12 weeks.\n* Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Subject has an unresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma, or an unresectable stage III-IV melanoma.\n* Subject is eligible for ICI treatment per Investigator judgement.\n* Subject has at least 1 measurable tumour lesion documented on CT\u002Fmagnetic resonance imaging (MRI) RECIST v1.1 during the last 12 months.\n* Subject has a tumour lesion(s) of which a biopsy can safely be obtained according to standard clinical care procedures.\n* Subject is male or female that agrees to adhere to the protocol contraception methods.\n\nExclusion Criteria:\n\n* Subject is unable to undergo all procedures in the study and\u002For is unable to remain still and tolerate the imaging procedure.\n* Subject has 12-lead ECG significant findings during screening, per Investigator's assessment.\n* Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.\n* Subject has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has B or T cell lymphoma.\n* Subject has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has signs or symptoms of systemic infection within 2 weeks prior to imaging day.\n* Subject has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and\u002For the proposed ICI therapy.\n* Subject has any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the ICI treatment, or that may affect the interpretation of the results or render the subject at high risk from complications.\n* Subject has laboratory values out of range per protocol.\n* Subject has any safety laboratory test results (blood chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.\n* Subject has had any major surgery within 4 weeks prior to enrollment.\n* Subject has been enrolled in another interventional clinical study within the 30 days before screening for this study, except for the study site IIS.\n* Subject is pregnant or planning to become pregnant or is breastfeeding.\n* Subject has a history of alcohol or drug abuse within the last year.\n* Subject has had treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to dosing with the IMP.\n* Subject has had treatment with systemic immunosuppressive medications within 2 weeks prior to dosing with the IMP.\n* Subject has received acute, low-dose, systemic immunosuppressant medications that, in the opinion of the Investigator, could compromise protocol objectives.\n* Subject has used systemic corticosteroids to treat inflammatory or autoimmune symptoms.",{"count":116,"type":20},[217],"Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days.\n\nPart B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment.\n\nSubjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit. Two late imaging transfer expected post follow up visit. The estimated duration for subject participation in Part B is approximately 64 days.",[287,288],"Malignant Solid Tumor","Oncology","2025-11-14",{"date":291,"type":32},"2025-11-17",{"date":293,"type":32},"2023-01-27",{"date":295,"type":20},"2029-03-10",{"name":38,"class":39},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":304,"targetDuration":306,"studyType":117,"phases":4,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":40},"100598050","clinical-performance-evaluation-of-a-diagnostic-ultrasound-system-100598050","NCT07066449","Clinical Performance Evaluation of a Diagnostic Ultrasound System","Clinical Performance Evaluation of the Vivid Pioneer Diagnostic Ultrasound System","Inclusion Criteria:\n\n1. Adults ≥ 18 years old, have autonomous capacity;\n2. Subjects who are required to undergo intraoperative transesophageal echocardiography according to the current clinical practice standards;\n3. Agree to participate in this study and have signed the subject Informed Consent Form.\n\nExclusion Criteria:\n\n1. Subjects who have been previously enrolled in this study or are participating in other clinical trials;\n2. Subjects with any medical emergency condition requiring urgent treatment;\n3. Pregnant females;\n4. Subjects with absolute contraindications of TEE (congenital or acquired upper digestive tract diseases, such as active upper gastrointestinal hemorrhage, esophageal obstruction or stenosis, esophageal tumor, esophageal lacerations and perforations, esophageal diverticula) or relative contraindications (changes in consciousness or lack of cooperation, history of cervical and mediastinal radiotherapy, history of recent esophageal surgery, esophageal varicosity, clotting disorders, cervical disease and injury, active esophagitis, active gastrointestinal ulcers, hiatal hernia, poor cardiopulmonary function, airway damage, pharyngeal space-occupying lesions, etc.), who are expected to be at high risks;\n5. Any other subjects who should not participate in this study in the investigator's opinion.",{"count":305,"type":20},60,"1 Day","Subjects who are required to undergo transesophageal echocardiography according to the current clinical practice standards will be eligible for enrollment. Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria. After successful screening and enrollment of subjects, the investigators will first use the investigational device to conduct transthoracic echocardiography (TTE), followed by transesophageal echocardiography (TEE). TEE will be conducted after the subject has been anesthetized. To avoid any delay in diagnosis and treatment, after the scan with the investigational device is completed, the probe will be reserved and the console will be switched to the existing commercial cardiac diagnostic ultrasound device in the study site for intraoperative guidance. In the study, each investigator will evaluate the overall image quality, user interface, workflow, user preferences, product preset, and functions of the system, as well as the device's safety and stability and fill out a user feedback questionnaire provided by the Sponsor.",[309],"Echocardiography","2025-09-15",{"date":312,"type":32},"2025-09-19",{"date":314,"type":32},"2025-08-12",{"date":316,"type":20},"2026-04",{"name":38,"class":39},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":325,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":40},"100580311","maternal-fetal-device-performance-twins-100580311","NCT06835647","Maternal Fetal Device Performance Twins","Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent.\n2. Twin pregnancy.\n3. Aged 18+.\n4. Greater than or equal to 30 0\u002F7 weeks gestation.\n5. Patient has none of the exclusion criteria.\n\nExclusion Criteria:\n\n1. Non-twin pregnancy.\n2. Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.\n3. Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.\n4. Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.","FEMALE",{"count":5,"type":20},[23],"Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.",[330],"Pregnancy",[330,332],"Twins","2025-07-10",{"date":335,"type":32},"2025-07-15",{"date":337,"type":32},"2025-01-21",{"date":339,"type":20},"2025-12-31",{"name":38,"class":39},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":350,"conditions":351,"keywords":355,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":40},"100530404","feasibility-of-a-deep-learning-based-algorithm-for-non-invasive-assessment-of-vulnerable-coronary-plaque-100530404","NCT06186336","Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque","FOCUS DL","Inclusion Criteria:\n\n1. Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;\n2. Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,\n3. Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.\n\nExclusion Criteria:\n\n1. Contradictions to contrast;\n2. Contraindications for beta blocker;\n3. BMI \\>30;\n4. High heart rate ≥75 BPM;\n5. Atrial Fibrillation;\n6. Arrythmia or irregular heartbeats;\n7. Any prior coronary revascularization;\n8. Presence of pacemaker or implantable cardioverter defibrillator; OR,\n9. Patients with TAVI\u002FTAVR.",{"count":349,"type":20},200,"The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.",[352,221,353,354],"Chronic Coronary Syndrome","Stable Angina","Acute Coronary Syndrome",[356,357,358,359],"Coronary CT Angiography","Invasive Coronary Angiography","Optical Coherence Tomography","Vulnerable Coronary Plaque","2025-01-06",{"date":362,"type":32},"2025-01-07",{"date":364,"type":20},"2025-01",{"date":366,"type":20},"2025-06",{"name":38,"class":39},""]