[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659291":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":59,"studyPopulation":60,"armGroups":61,"interventions":16,"overallOfficials":16,"centralContacts":65,"locations":75,"responsibleParty":127,"collaborators":16,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":16,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":16,"enrollmentInfo":138,"targetDuration":141,"studyType":142,"phases":16,"briefSummary":143,"conditions":144,"keywords":16,"overallStatus":146,"whyStopped":16,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Intuitive Surgical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic yield assessed using the ATS\u002FACCP consensus definition.","Diagnostic yield will be calculated according to the ATS\u002FACCP consensus definition using the diagnosis established from the index biopsy procedure.","At completion of index biopsy procedure",[14,18,20,23,26,29,31],{"measure":15,"description":16,"timeFrame":17},"Intermediate diagnostic yield",null,"Through establishment of final diagnosis (up to 12 months)",{"measure":19,"description":16,"timeFrame":17},"Sensitivity for malignancy",{"measure":21,"description":16,"timeFrame":22},"Rate of pneumothorax (with and without intervention or hospitalization)","within 7 days post procedure.",{"measure":24,"description":16,"timeFrame":25},"Rate of intra-procedure airway bleeding graded using the Nashville Bleeding Scale","Procedure day",{"measure":27,"description":16,"timeFrame":28},"Procedure time (ssRAB catheter in or out)","During the index biopsy procedure.",{"measure":30,"description":16,"timeFrame":28},"Total radiation dose",{"measure":32,"description":16,"timeFrame":33},"Number of cone beam CT (CBCT) spins","During the index biopsy procedure",[35,37,39,42,45,48,50,53],{"measure":36,"description":16,"timeFrame":28},"Rate of successful tool in lesion (TIL)",{"measure":38,"description":16,"timeFrame":28},"rEBUS view at time of tissue sampling (when radial EBUS is used)",{"measure":40,"description":16,"timeFrame":41},"Rate of procedure related adverse events.","30 days post-procedure or until the next invasive diagnostic or therapeutic intervention, whichever occurs first.",{"measure":43,"description":16,"timeFrame":44},"Time from identification of nodule to diagnosis","Through establishment of final diagnosis (up to 12 months).",{"measure":46,"description":16,"timeFrame":47},"Rate and type of imaging and\u002For diagnostic interventions performed from nodule identification to procedure","Up to the index biopsy procedure.",{"measure":49,"description":16,"timeFrame":44},"Percentage of patients and timepoint for invasive mediastinal staging.",{"measure":51,"description":16,"timeFrame":52},"Adequacy of biopsy sample for molecular\u002Fimmunohistochemistry (IHC) testing when indicated.","Up to 30 days after the index biopsy procedure.",{"measure":54,"description":16,"timeFrame":55},"Patient-reported outcomes measured with the EQ-5D-5L.","Up to 7 days post-procedure.",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":57,"timePerspective":58,"maskingInfo":16},"COHORT","PROSPECTIVE","Lung cancer remains a leading cause of cancer-related mortality worldwide, and delayed diagnosis is an important contributor to poor clinical outcomes. Earlier and more accurate diagnosis of small peripheral pulmonary nodules may facilitate timely clinical decision-making and treatment.\n\nThe Ion Endoluminal System is a robotic-assisted bronchoscopy platform designed to provide access to peripheral pulmonary lesions. When integrated with mobile cone-beam computed tomography (mCBCT), the system may provide additional imaging information to support localization of small pulmonary nodules during bronchoscopic biopsy. However, prospective clinical data on the diagnostic performance of this integrated approach in small, bronchus sign-negative pulmonary nodules remain limited.\n\nROBISN is a prospective, multicenter, observational study designed to evaluate the clinical performance of bronchoscopic biopsy using the integrated Ion Endoluminal System and mCBCT platform in patients with small peripheral pulmonary nodules that are considered challenging for conventional bronchoscopic biopsy.\n\nThe study will enroll adult patients who are already clinically planned to undergo bronchoscopic biopsy using the Ion Endoluminal System and mCBCT as part of their routine clinical care. Eligible patients will have a single target pulmonary nodule with a maximum diameter of 20 mm or less, measured on axial, sagittal, and coronal computed tomography images. The target nodule must also be bronchus sign-negative on thin-section computed tomography.\n\nThis is an observational study, and participation in the study will not determine the patient's clinical diagnostic or treatment pathway. All bronchoscopic procedures, imaging, biopsy techniques, pathology assessments, subsequent diagnostic evaluations, and treatment decisions will be performed according to the participating institution's standard clinical practice and the treating physician's judgment.\n\nThe study will prospectively collect information related to patient and target lesion characteristics, procedural details, use of adjunctive imaging and biopsy modalities, biopsy results, pathology findings, procedure-related adverse events, and subsequent clinical information used to establish the final diagnosis of the target pulmonary nodule.\n\nDiagnostic outcomes will be assessed using information obtained from the index bronchoscopic biopsy together with subsequent pathology, imaging, clinical follow-up, or other diagnostic procedures, as applicable. Follow-up information will be collected prospectively to evaluate the diagnostic outcome of cases in which the initial biopsy result is not immediately definitive and to characterize the clinical course of the target lesion over time.\n\nSafety outcomes will include clinically relevant procedure-related adverse events, including events such as pneumothorax and bleeding. Other procedural and clinical variables will also be collected to characterize the performance of the integrated Ion Endoluminal System and mCBCT approach in this patient population.\n\nThe results of this study are intended to provide prospective, multicenter evidence regarding the use of robotic-assisted bronchoscopy combined with mCBCT for the biopsy of small, bronchus sign-negative pulmonary nodules and to better characterize its diagnostic performance and safety in routine clinical practice.","Adults planned to undergo a pulmonary nodule biopsy using the Ion Endoluminal System and integrated mobile cone beam CT (mCBCT)",[62],{"label":63,"type":16,"description":64,"interventionNames":16},"Patients Undergoing Ion Robotic Bronchoscopy With mCBCT","Adult patients with a single small, bronchus sign-negative pulmonary nodule who are clinically planned to undergo bronchoscopic biopsy using the integrated Ion Endoluminal System and mobile cone-beam computed tomography (mCBCT) platform as part of routine clinical care.",[66,72],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Changmin Oh","CONTACT","+82-2-3271-3200","3253","changmin.oh@intusurg.com",{"name":73,"role":68,"phone":16,"phoneExt":16,"email":74},"Chunsik Eum","chunsik.eum@intusurg.com",[76,91,103,115],{"facility":77,"status":16,"city":78,"state":79,"zip":80,"country":81,"countryCode":16,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"National Cancer Center","Goyang-si","Gyeonggi-do","10408","South Korea",{"type":83,"coordinates":84},"Point",[85,86],126.835,37.65639,{"lat":86,"lon":85},[89],{"name":90,"role":68,"phone":16,"phoneExt":16,"email":16},"Bin Hwangbo, MD, PhD",{"facility":92,"status":16,"city":93,"state":16,"zip":94,"country":81,"countryCode":16,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Chungnam National University Hospital","Daejeon","35015",{"type":83,"coordinates":96},[97,98],127.38493,36.34913,{"lat":98,"lon":97},[101],{"name":102,"role":68,"phone":16,"phoneExt":16,"email":16},"Dongil Park, MD, PhD",{"facility":104,"status":16,"city":105,"state":16,"zip":106,"country":81,"countryCode":16,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Samsung Medical Center","Seoul","06351",{"type":83,"coordinates":108},[109,110],126.9784,37.566,{"lat":110,"lon":109},[113],{"name":114,"role":68,"phone":16,"phoneExt":16,"email":16},"KyungJong Lee, MD, PhD",{"facility":116,"status":16,"city":117,"state":16,"zip":118,"country":81,"countryCode":16,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Ulsan University Hospital","Ulsan","44033",{"type":83,"coordinates":120},[121,122],129.31667,35.53722,{"lat":122,"lon":121},[125],{"name":126,"role":68,"phone":16,"phoneExt":16,"email":16},"Ganghee Chae, MD, PhD",{"type":128,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100659291","robotic-bronchoscopy-for-small-lung-nodules-without-a-bronchus-sign-100659291",false,"NCT07862816","Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign","ROBISN: Shape-sensing Robotic-assisted Bronchoscopy for Investigation of Small, Bronchus Sign Absent Nodules","Inclusion Criteria:\n\n* Patient is aged 19 years or older at the time of consent.\n* Single pulmonary nodule planned for biopsy with the integrated Ion Endoluminal System\u002FmCBCT platform.\n* Target pulmonary nodule (solid or subsolid) with overall largest diameter ≤20 mm and solid component \\>5 mm in largest diameter, measured across axial, sagittal, and coronal CT.\n* Target pulmonary nodule is bronchus sign negative on thin section CT (≤1 mm).\n\nExclusion Criteria:\n\n* Patient is planned for non-surgical oncological treatment (e.g., SBRT, chemotherapy) regardless of biopsy outcome.\n* Patient with a nodule that is amenable to linear EBUS sampling.\n* More than one target pulmonary nodule planned for biopsy during the index bronchoscopy procedure.\n* Patient has a history of pneumonectomy.\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, Institution, or Investigator.\n* Patient is not willing or able (as deemed by the Investigator) to comply with study participation requirements.\n* Investigator, in their professional opinion, has decided that it is in the patient's best interest not to participate in the clinical study.\n* Patient is pregnant, nursing, or planning to become pregnant.","ALL","19 Years",{"count":139,"type":140},151,"ESTIMATED","12 Months","OBSERVATIONAL","The goal of this observational study is to learn about the diagnostic performance and safety of robotic-assisted bronchoscopy using the Ion Endoluminal System in adults with small lung nodules that do not show a bronchus sign on CT imaging.\n\nThe main questions it aims to answer are:\n\n* How effective is robotic-assisted bronchoscopy in obtaining a diagnosis for small lung nodules without a bronchus sign?\n* How safe is the procedure, including the risk of complications such as pneumothorax and bleeding?\n\nParticipants who are already scheduled to undergo lung nodule biopsy using the Ion Endoluminal System and integrated mobile cone-beam CT (mCBCT) as part of their routine clinical care will be enrolled in this study.",[145],"Lung Cancer (Diagnosis)","NOT_YET_RECRUITING","2026-10-02",{"date":149,"type":150},"2026-10-07","ACTUAL",{"date":152,"type":140},"2027-01",{"date":154,"type":140},"2029-03",{"name":5,"class":6},4]