[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoventilation-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoventilation-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100626173","medical-device-clinical-trial-without-ce-marking-to-evidence-safety-and-performance-of-the-inbentus-versatile-ventilator-in-patients-requiring-assistedcontrolled-mechanical-ventilation-and-weaning-100626173",false,"NCT07432191","Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted\u002FControlled Mechanical Ventilation and Weaning.","Inclusion Criteria:\n\n* Participants ≥ 18 years of age at the time of consent.\n* Participants requiring invasive mechanical ventilation for a period of ≥3 hours.\n* Participants must provide written informed consent.\n\nExclusion Criteria:\n\n1. Participants requiring anesthetic delivery systems or aerosol nebulizer systems.\n2. Participants requiring modifications to the ventilator circuit, such as those treated with nitric oxide (iNO).\n3. Any participant determined by the research team to be hemodynamically unstable, defined as:\n\n   1. MAP \\\u003C 65 mmHg despite vasoactive drugs.\n   2. Systolic Blood Pressure \\> 180 mmHg.\n   3. Diastolic Blood Pressure \\> 110 mmHg.\n   4. Severe volume loss (\\>30% of blood volume) with persistent signs of hypoperfusion.\n4. Life expectancy of less than 12 months.\n5. Pregnant women at the time of informed consent.","ALL","18 Years",{"count":18,"type":19},81,"ESTIMATED","INTERVENTIONAL",[22],"NA","Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator.\n\nThe 81 aldult participants are ventilated between 3 and 48 hours with invasive mechanical ventilation (IMV) in assisted\u002Fcontrolled mode and weaning under partial pressure support or volume support, followed by monitoring period until ICU discharge, hospital discharge or 30 days.\n\nThe study design differentiates between a Validation Cohort (up to 20 participants) for device validation and a Study Cohort (up to 61 participants) for safety and performance confirmation.\n\nSerious Adverse Events related to study device and\u002For its procedure is defined as the primary safety endpoint, whereas technical failure rate is defined as the primary performance endpoint.",[25,26,27,28,29,30,31],"Acute Respiratory Distress Syndrome (ARDS)","Pneumonia","COPD (Chronic Obstructive Pulmonary Disease)","Postoperative Respiratory Distress","Hypoventilation Syndrome","Hypoxemia","Hypercapnia","RECRUITING","2026-02-18",{"date":35,"type":36},"2026-02-25","ACTUAL",{"date":38,"type":36},"2025-05-29",{"date":40,"type":19},"2026-11",{"name":42,"class":43},"Iconic Solutions By Murcia SL","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100623897","sleep-disordered-breathing-database-100623897","NCT07402603","Sleep-disordered Breathing Database","Enhancing Patient Care: Sleep and Ventilation Database","Inclusion Criteria:\n\n* Age \\>18 years\n* Referred to Royal Free London NHS Foundation Trust Sleep and Ventilation Service\n* Agreed to undertake a sleep study\n\nExclusion Criteria:\n\n* Inability to consent",true,{"count":54,"type":19},5000,"5 Years","OBSERVATIONAL","The goal of this study is to collect clinical data on patients who have had a sleep study and are given a diagnosis of a sleep related breathing disorder such as obstructive sleep apnoea. Collecting this data in an organised way will mean that the investigators can monitor patients and their health outcomes.",[59,29],"Obstructive Sleep Apnoea (OSA)",[61,62],"database","observational","NOT_YET_RECRUITING","2026-02-04",{"date":66,"type":36},"2026-02-11",{"date":68,"type":19},"2026-01-15",{"date":70,"type":19},"2036-01",{"name":72,"class":73},"Royal Free Hospital NHS Foundation Trust","OTHER"]