[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520094":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Hangzhou Broncus Medical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transbronchial group","EXPERIMENTAL","Subjects receive bronchoscopy-guided RFA and undergo follow-up.",[13],"Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system",{"label":15,"type":10,"description":16,"interventionNames":17},"Transthoracic group","Subjects receive CT-guided RFA and undergo follow-up.",[18],"Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system","Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system","Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.",[15],[31],{"name":32,"affiliation":33,"role":34},"Jiayuan Sun, MD, PhD","Shanghai Chest Hospital","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","86-021-22200000","1511","xkyyjysun@163.com",[42],{"facility":33,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Shanghai","Shanghai Municipality","200030","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56,57],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[61],{"name":33,"class":62},"OTHER","100520094","transbronchial-vs-transthoracic-ablation-for-early-stage-peripheral-lung-cancer-100520094",false,"NCT06052098","Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer","Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age greater than 18 years.\n2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.\n3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.\n4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with platelet \\\u003C 50 × 10 9\u002FL, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.\n2. Patients with severe pulmonary fibrosis and pulmonary hypertension.\n3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \\> 38.5℃.\n4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.\n5. Patients with poorly controlled malignant pleural effusion.\n6. Anticoagulation therapy and\u002For antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\\~7 days before ablation.\n7. Eastern Cooperative Oncology Group (ECOG) score \\> 2.\n8. Combined with other tumors with extensive metastasis, expected survival \\\u003C 6 months.\n9. Patients with episodic psychosis.\n10. Patients with implantable electronic devices (such as pacemaker or defibrillator).\n11. Pregnant women, or patients who have pregnancy plans during the study.\n12. Participation or ongoing participation in another clinical study within the past 30 days.\n13. Other situations that the investigator deems inappropriate to participate in this study.","ALL","18 Years",{"count":73,"type":74},110,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.",[80],"Stage IA Lung Cancer","2023-11-30",{"date":83,"type":84},"2023-12-06","ACTUAL",{"date":86,"type":84},"2023-10-11",{"date":88,"type":74},"2027-10",{"name":5,"class":6},1]