[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656929":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":44,"armGroups":52,"interventions":59,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":86,"collaborators":44,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":44,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":44,"enrollmentInfo":97,"targetDuration":44,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":44,"overallStatus":105,"whyStopped":44,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Shanghai Chest Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Technical Success Rate (Lesion Level)","The proportion of lesions achieving effective ablation under 5G-enabled remote robotic-assisted bronchoscopy guidance among all lesions that undergo ablation. Effective ablation is defined as an immediate post-procedural imaging finding demonstrating an ablation zone extending at least 5 mm beyond the margin of the target lesion.","Immediately after procedure",[14,18,22,25,28,31,34,37,40],{"measure":15,"description":16,"timeFrame":17},"Complete Ablation Rate at 6 Months (Lesion Level)","The proportion of lesions that maintain complete ablation at 6 months after transbronchial cryoablation among all lesions that undergo ablation.","6 months",{"measure":19,"description":20,"timeFrame":21},"Complete Ablation Rate at 12 Months (Lesion Level)","The proportion of lesions that maintain complete ablation at 12 months after transbronchial cryoablation among all lesions that undergo ablation.","12 months",{"measure":23,"description":24,"timeFrame":17},"Intrapulmonary Progression-Free Survival Rate at 6 Months (Patient Level)","The proportion of patients without intrapulmonary disease progression at 6 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.",{"measure":26,"description":27,"timeFrame":21},"Intrapulmonary Progression-Free Survival Rate at 12 Months (Patient Level)","The proportion of patients without intrapulmonary disease progression at 12 months after transbronchial cryoablation among all patients who undergo ablation. Absence of intrapulmonary progression is defined as maintenance of imaging-confirmed non-progression of the treated lesion(s), absence of hilar lymph node metastasis, and absence of new lesions.",{"measure":29,"description":30,"timeFrame":21},"Overall Survival Rate at 12 Months (Patient Level)","The proportion of patients who remain alive at 12 months after transbronchial cryoablation among all patients who undergo ablation.",{"measure":32,"description":33,"timeFrame":12},"Remote Image Transmission Latency","Remote image transmission latency is defined as the sum of local image latency, network transmission latency, and image encoding\u002Fdecoding latency.",{"measure":35,"description":36,"timeFrame":12},"Remote Control Latency","Remote control latency is defined as the sum of control computation latency, mechanical response latency, and network transmission latency.",{"measure":38,"description":39,"timeFrame":12},"Packet Loss Rate","Packet loss rate is calculated as the number of lost data packets divided by the total number of data packets transmitted by the sender.",{"measure":41,"description":42,"timeFrame":43},"Safety (Patient Level)","The incidence of device- or ablation-related adverse events occurring intraoperatively or within 1 month after the procedure.","1 month",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE","This is a prospective, multicenter, single-arm, and open-label clinical study. In this study, 15 patients will be enrolled to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Patients with pulmonary malignancies","EXPERIMENTAL","15 patients with pulmonary malignancies who meet the inclusion and exclusion criteria will be prospectively enrolled. 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation will be performed to treat the lesions.",[58],"Procedure: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":44},"PROCEDURE","5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation","All procedures will be performed under general anesthesia with endotracheal intubation. The operator will remotely manipulate the control console to navigate the robotic bronchoscope to the target bronchus. For lesions with no ideal bronchial access, a tunnel to the target lesion will be established by needle puncture. Radial endobronchial ultrasound (rEBUS) may be selectively used to identify and confirm the lesion location. The cryoablation probe will be advanced into the lesion through the bronchus or the established tunnel. After confirming the position of the cryoablation probe using cone-beam computed tomography (CBCT), cryoablation will be performed. Immediately after cryoablation, CBCT will be performed to evaluate the spatial relationship between the ablation zone and the target lesion. An imaging safety margin extending at least 5 mm beyond the margin of the target lesion will serve as an important criterion for technical success.",[54],[66],{"name":67,"affiliation":5,"role":68},"Jiayuan Sun","PRINCIPAL_INVESTIGATOR",[70],{"name":67,"role":71,"phone":72,"phoneExt":73,"email":74},"CONTACT","+86-021-22200000","1511","xkyyjysun@163.com",[76],{"facility":5,"status":44,"city":77,"state":44,"zip":44,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":44},"Shanghai","China","CN",{"type":81,"coordinates":82},"Point",[83,84],121.45806,31.22222,{"lat":84,"lon":83},{"type":68,"investigatorFullName":67,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Director, Department of Respiratory Endoscopy","100656929","5g-enabled-remote-robotic-assisted-bronchoscopy-guided-cryoablation-for-pulmonary-malignancies-100656929",false,"NCT07830095","5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies","A Feasibility Study on 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies: A Prospective, Multicenter, Single-Arm Clinical Study (BRIDGE Study)","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Pathologically confirmed non-small cell lung cancer, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3; or metastatic lung tumors with the primary lesion well controlled, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n4. Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.\n5. Determined to be unsuitable for or unwilling to undergo antitumor drug therapy.\n6. Considered technically feasible for robotic-assisted bronchoscopy-guided cryoablation of the target lesion(s).\n7. Provided written informed consent after being fully informed of the study procedures, potential benefits, and risks.\n\nExclusion Criteria:\n\n1. Unable to tolerate or unwilling to undergo general anesthesia.\n2. Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.\n3. Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.\n4. Evidence of intrathoracic lymph node metastases or extrathoracic metastases within 1 month before the procedure, except for extrathoracic metastases that had been effectively controlled by local treatment.\n5. Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count \\\u003C50 × 10\\^9\u002FL, prothrombin time \\>18 s, or prothrombin activity \\\u003C40%.\n6. Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure.\n7. Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study.\n8. Uncontrolled infectious disease.\n9. Severe concomitant pulmonary disease, including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, or pulmonary hypertension, considered by the investigator to preclude participation in the study.\n10. Acute cardiovascular or cerebrovascular events, such as acute ischemic stroke or acute coronary syndrome, within 3 months before enrollment.\n11. A history of severe cardiac dysfunction and\u002For severe cardiac arrhythmia.\n12. Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment.\n13. Pregnancy or lactation, or plans to become pregnant during the study period;\n14. Any other condition considered by the investigator to make the patient unsuitable for enrollment.","ALL","18 Years",{"count":98,"type":99},15,"ESTIMATED","INTERVENTIONAL",[46],"The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.",[104],"Lung Cancer","NOT_YET_RECRUITING","2026-09-15",{"date":108,"type":109},"2026-09-21","ACTUAL",{"date":111,"type":99},"2026-09-30",{"date":113,"type":99},"2027-12-31",{"name":5,"class":6},1]