[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Corsano Health B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100643350","multi-centre-based-evaluation-of-the-performance-and-safety-of-the-corsano-cardiowatch-287-2-blood-pressure-monitoring-device-at-wrist-against-bp-cuff-measurements-cor-bp-100643350",false,"NCT07633886","Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)","COR-BP","Inclusion Criteria:\n\n* Participants must be able to provide informed consent to participate.\n* Participants must be willing and able to comply with all of the study procedures and return for at least 3 visits.\n* Participant or witness must be able to read or write in Dutch or English.\n* Applicable for group A: Participant must be 22 to 50 years of age.\n* Applicable for group B: Participant must be over 50 years of age.\n\nExclusion Criteria:\n\n* Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized).\n* Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.\n* Participants with known clotting disorders or currently taking a prescription blood thinner.\n* Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.\n* Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \\> 120bpm) and atrial fibrillation.\n* Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \\\u003C 60mL \u002F min \u002F 1.73 m2), hyper- \u002F hypothyroidism, pheochromocytoma or arteriovenous fistula.\n* Participants with known aortic arch pathology or prior surgical intervention involving the aortic arch or descending aorta (e.g., coarctation repair, vascular grafting, or stenting), which may interfere either with accurate peripheral blood pressure measurement.\n* A wrist circumference below 14 cm or above 23 cm.\n* An upper arm circumference \\\u003C 22cm or \\> 42cm.\n* Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study (i.e. to ensure all sub-groups have adequate representation).\n* Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and\u002For more than 10 mmHg for the diastolic.\n\nAdditional criteria that will be pursued for ensuring demographic diversity consist of the following patient characteristics according to FDA recommendations concerning the diversity of clinical trial populations \\[6\\]:\n\n* Gender, at least:\n\n  * 40% female;\n  * 40% male.\n* Skin Colour, at least:\n\n  * 25% Monk skin tone (MST) 1-3;\n  * 25% MST 4-6;\n  * 25% MST 7-10 including subjects with MST 9 and MST 10.\n* BMI, at least:\n\n  * 5% Underweight (\\\u003C18.5)\n  * 20% Normal weight (18.5-24.9)\n  * 20% Overweight (25-29.9)\n  * 20% Obese (≥30.0)","ALL","22 Years",{"count":19,"type":20},170,"ESTIMATED","OBSERVATIONAL","The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic groups.\n\nPrimary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and auscultatory blood pressure monitoring over a period of 31 days.\n\nSecondary objective: To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.\n\nParticipants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. The study group will include patients of different ages (above the age of 22 years), genders, and demographics.",[24],"Blood Pressure Monitoring, Ambulatory",[26,27,28,29],"Blood pressure","Remote monitoring","Wearable","Corsano CardioWatch","NOT_YET_RECRUITING","2026-06-05",{"date":33,"type":34},"2026-06-08","ACTUAL",{"date":36,"type":20},"2026-06",{"date":38,"type":20},"2026-09",{"name":40,"class":41},"Corsano Health B.V.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100588510","comparative-evaluation-of-body-temperature-measurement-using-the-cardiowatch-287-2-in-an-intensive-care-setting-100588510","NCT06942338","Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.","Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 2870-2 and Invasive Temperature Monitoring in an Intensive Care Setting.","ICU-temp","Inclusion Criteria:\n\n* ≥ 18 years old;\n* Able to provide consent\n* Administered at the ICU or recovery room of the Reinier de Graaf hospita\n\nExclusion Criteria:\n\n* Unable to wear the Corsano CardioWatch 287 or Radius-T sensor due to reasons such as allergic reactions, wounds, amputations etc.;\n* Unable to receive rectal temperature monitoring;\n* Thermoregulatory problems or diseases;\n* Hyperthermia (\\>40°C);\n* Known allergy to plastics \u002F latex;\n* Patient not willing to sign informed consent;\n* Significant mental or cognitive impairment.","18 Years",{"count":52,"type":20},120,"Fever is a common symptom in many health conditions, but current methods to monitor body temperature (BT) are either invasive, costly, or not continuous. The Corsano CardioWatch 287-2, a wristband that tracks multiple vital signs, offers a new way to monitor BT by measuring skin temperature and heat flux on the wrist. It uses a machine learning algorithm to predict BT in real-time. The device has shown good results when compared to other non-invasive temperature measurements, like tympanic (ear) temperature, in stroke patients. However, it hasn't yet been compared to the gold standard of invasive rectal temperature monitoring in a clinical setting. This study aims to test the accuracy of the Corsano CardioWatch 287-2 in measuring body temperature against rectal temperature monitoring in a clinical environment.",[55,56],"ICU Hospitalization","Surgical Intervention",[58,59,60,61,62,63],"wristband","wearable","body temperature","validation","rectal temperature","remote monitoring","2026-06-01",{"date":66,"type":34},"2026-06-02",{"date":36,"type":20},{"date":69,"type":20},"2026-12",{"name":40,"class":41},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":71},"100589504","multi-centre-based-study-recognition-of-atrial-fibrillation-with-the-corsano-cardiowatch-287-2-system-100589504","NCT06955273","Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System","COR-AF","Inclusion Criteria:\n\n* Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation\n* Age ≥ 22 years old\n* Able to provide informed consent.\n* Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.\n\nExclusion Criteria:\n\n* Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;\n* Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;\n* Unable or not willing to receive ECG monitoring;\n* Unable or not willing to sign informed consent;",true,{"count":81,"type":20},350,"This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter.\n\nTo ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited:\n\n* Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring\n* Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.\n* Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.\n* Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.\n\nThe secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.",[84,85],"Atrial Fibrillation (AF)","Paroxysmal Atrial Fibrillation (PAF)",[58,59,87,88,89,63,61],"atrial fibrillation","holter","ecg","2025-04-30",{"date":92,"type":34},"2025-05-02",{"date":94,"type":20},"2025-05-01",{"date":96,"type":20},"2026-01",{"name":40,"class":41},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":71},"100587626","frailty-classification-algorithm-for-the-corsano-cardiowatch-287-2-a-development-and-validation-study-100587626","NCT06930833","FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study","FRAILTY-CW2","Inclusion Criteria:\n\n* ≥ 70 years old\n* Be able to provide consent\n* Be scheduled to undergo one of the following procedures:\n\n  * Aortic valve replacement\n  * Mitral valve repair with MitraClip\n  * Implantation of a pacemaker\n  * Percutaneous coronary intervention (PCI)\n\nExclusion Criteria:\n\n* Unable to wear the Corsano CardioWatch 287-2 due to reasons such as allergic reactions, wounds, amputations etc.;\n* Unable or unwilling to sign informed consent;\n* Significant mental or cognitive impairment;\n* Cardiovascular disease where heart rate is not measurable (e.g. LVAD)","70 Years",{"count":107,"type":20},20,"The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation.\n\nThe study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm.\n\nThe main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.",[110,111,112],"Cardiac Arrythmias","Valve Heart Disease","Cardiac Ischemia",[114,115,116,58,59,63,117],"Frailty","6-minute walking test","G8-score","cardiac surgical interventions","2025-04-16",{"date":120,"type":34},"2025-04-20",{"date":122,"type":20},"2025-05",{"date":124,"type":20},"2026-10",{"name":40,"class":41},""]