Remote Robotic Bronchoscopy Cryoablation Over 5G for Lung Cancer

Trial details

Who runs it

Shanghai Chest Hospital

Trial code

NCT07830095

Record updated

6 November 2026

Original description

The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.Read full original descriptionShow less

A Feasibility Study on 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies: A Prospective, Multicenter, Single-Arm Clinical Study (BRIDGE Study)

The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.

Inclusion: Age ≥18 years; Pathologically confirmed or highly suspected following preoperative multidisciplinary discussion to have either: (a) primary peripheral lung cancer, with preoperative staging investigations indicating clinical stage T1N0M0, stage IA, including newly developed primary lung cancer after previous lung cancer surgery and multiple primary lung cancers; or (b) metastatic lung tumors with the primary tumor well controlled. The target lesions must have a maximum diameter ≤3 cm, with no more than 3 lesions planned for ablation. For patients without a preoperative pathological diagnosis, malignancy must be confirmed by intraoperative biopsy and pathological assessment, and all other conditions for ablation must be met before cryoablation is performed during the same procedure; Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; Determined by multidisciplinary assessment to be unsuitable for or unwilling to undergo surgery and radiotherapy; Considered technically feasible for robotic-assisted bronchoscopy-guided cryoablation of the target lesion(s); Provided written informed consent after being fully informed of the study procedures, potential benefits, and risks.

Exclusion: Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure; 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; Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure; 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; Acute cardiovascular or cerebrovascular events, such as acute ischemic stroke or acute coronary syndrome, within 3 months before enrollment; Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment; Uncontrolled infectious disease; A history of severe cardiac dysfunction and/or severe cardiac arrhythmia; Any other condition considered by the investigator to make the patient unsuitable for enrollment; Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count <50 × 10\^9/L, prothrombin time >18 s, or prothrombin activity <40%; Unable to tolerate or unwilling to undergo general anesthesia; Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy; Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study; Pregnancy or lactation, or plans to become pregnant during the study period.

ClinicalTrials.gov NCT07830095