[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587083":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":34,"overallOfficials":22,"centralContacts":40,"locations":48,"responsibleParty":168,"collaborators":22,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":22,"eligibilityCriteria":176,"healthyVolunteers":172,"sex":177,"minAge":178,"maxAge":22,"enrollmentInfo":179,"targetDuration":182,"studyType":183,"phases":22,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":67,"whyStopped":22,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"Intuitive Surgical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic Yield","Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.","Intra-procedure through 24 month post-procedure",[14,18],{"measure":15,"description":16,"timeFrame":17},"Pneumothorax","Defined as the incidence of subjects that undergo an Ion procedure with a pneumothorax event, requiring intervention","Intra-procedure through 30 days post-procedure",{"measure":19,"description":20,"timeFrame":21},"Bleeding","Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale","Intra-procedure through the 30 day post-procedure",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"COHORT","PROSPECTIVE","This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and\u002For localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and\u002For localization procedure attempted or performed.","Patients planned for an elective lung nodule biopsy and\u002For localization procedure using the Ion endoluminal system as their standard of care",[29],{"label":30,"type":22,"description":31,"interventionNames":32},"Observation Group","Subjects with biopsy and\u002For localization of lung nodule(s)",[33],"Device: Ion endoluminal system",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":22},"DEVICE","Ion endoluminal system","Lung nodule biopsy and\u002For localization procedure using the Ion endoluminal system per sites' standard of care",[30],[41,46],{"name":42,"role":43,"phone":44,"phoneExt":22,"email":45},"Jana Meschede","CONTACT","+41 21 821 2000","IonEURegistry@intusurg.com",{"name":47,"role":43,"phone":44,"phoneExt":22,"email":45},"Martha Bean",[49,65,78,90,104,116,128,142,156],{"facility":50,"status":51,"city":52,"state":22,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"CHU de Brest, Hôpital de La Cavale Blanche","NOT_YET_RECRUITING","Brest","29200","France","FR",{"type":57,"coordinates":58},"Point",[59,60],-4.48628,48.39029,{"lat":60,"lon":59},[63],{"name":64,"role":43,"phone":22,"phoneExt":22,"email":22},"Christophe Gut-Gobert, Dr.",{"facility":66,"status":67,"city":68,"state":22,"zip":69,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Hôpital Marie Lannelongue","RECRUITING","Le Plessis-Robinson","92350",{"type":57,"coordinates":71},[72,73],2.27078,48.78889,{"lat":73,"lon":72},[76],{"name":77,"role":43,"phone":22,"phoneExt":22,"email":22},"Amir Hanna, Dr.",{"facility":79,"status":51,"city":80,"state":22,"zip":81,"country":54,"countryCode":55,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"CHU de Rouen","Rouen","76031",{"type":57,"coordinates":83},[84,85],1.09932,49.44313,{"lat":85,"lon":84},[88],{"name":89,"role":43,"phone":22,"phoneExt":22,"email":22},"Samy Lachkar, Dr.",{"facility":91,"status":67,"city":92,"state":22,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Helios Klinikum Emil von Behring","Berlin","14165","Germany","DE",{"type":57,"coordinates":97},[98,99],13.41053,52.52437,{"lat":99,"lon":98},[102],{"name":103,"role":43,"phone":22,"phoneExt":22,"email":22},"Joanna Krist, Dr.",{"facility":105,"status":67,"city":106,"state":22,"zip":107,"country":94,"countryCode":95,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"DGD Lungenklining Hemer","Hemer","58675",{"type":57,"coordinates":109},[110,111],7.77019,51.38707,{"lat":111,"lon":110},[114],{"name":115,"role":43,"phone":22,"phoneExt":22,"email":22},"Kaid Darwiche, Prof. Dr.",{"facility":117,"status":67,"city":118,"state":22,"zip":119,"country":94,"countryCode":95,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Helios Dr. Horst Schmidt Kliniken","Wiesbaden","65199",{"type":57,"coordinates":121},[122,123],8.24435,50.08601,{"lat":123,"lon":122},[126],{"name":127,"role":43,"phone":22,"phoneExt":22,"email":22},"Tim Hirche, Prof. Dr.",{"facility":129,"status":67,"city":130,"state":22,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Universitätsspital Zürich","Zurich","8091","Switzerland","CH",{"type":57,"coordinates":135},[136,137],8.55,47.36667,{"lat":137,"lon":136},[140],{"name":141,"role":43,"phone":22,"phoneExt":22,"email":22},"Carolin Steinack, PD Dr.",{"facility":143,"status":67,"city":144,"state":22,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"University College London Hospitals NHS Foundation Trust","London","NW1 2BU","United Kingdom","UK",{"type":57,"coordinates":149},[150,151],-0.12574,51.50853,{"lat":151,"lon":150},[154],{"name":155,"role":43,"phone":22,"phoneExt":22,"email":22},"Ricky Thakrar, Dr.",{"facility":157,"status":67,"city":158,"state":22,"zip":159,"country":146,"countryCode":147,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Wythenshawe Hospital, Manchester University NHS Foundation Trust","Manchester","M23 9LT",{"type":57,"coordinates":161},[162,163],-2.23743,53.48095,{"lat":163,"lon":162},[166],{"name":167,"role":43,"phone":22,"phoneExt":22,"email":22},"Haval Balata, Dr.",{"type":169,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100587083","european-real-world-registry-for-use-of-the-ion-endoluminal-system-100587083",false,"NCT06923774","European Real-World Registry for Use of the Ion Endoluminal System","A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System","Inclusion Criteria:\n\n* Patient is aged 18 years or older at time of consent.\n* Patient is planned to undergo a lung lesion biopsy(s) and\u002For localization procedure(s) utilizing the Ion endoluminal system.\n* Patient is willing and able to give written informed consent for clinical study participation.\n\nExclusion Criteria:\n\n* Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.\n* Female patient that is pregnant or breast feeding as determined by standard site practices.\n* Patient is legally incapacitated or in a legal\u002Fcourt ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.\n* Patient is not willing to comply with post-procedure study participation requirements.\n* Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.","ALL","18 Years",{"count":180,"type":181},1200,"ESTIMATED","24 Months","OBSERVATIONAL","The objective of this study is to collect collect real-world data for the Ion endoluminal system.",[186,187],"Pulmonary Nodule","Lung Cancer",[189,190,191,192],"Biopsy","Bronchoscopy","pulmonary biopsy","pulmonary nodule localization","2026-10-08",{"date":195,"type":196},"2026-10-09","ACTUAL",{"date":198,"type":196},"2025-09-09",{"date":200,"type":181},"2029-10",{"name":5,"class":6},9]