5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies

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.

Inclusion criteria

• Age ≥18 years.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
• Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.
• Determined to be unsuitable for or unwilling to undergo antitumor drug therapy.
• 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 criteria

• Unable to tolerate or unwilling to undergo general anesthesia.
• Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.
• 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.
• Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count <50 × 10^9/L, prothrombin time >18 s, or prothrombin activity <40%.
• Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure.
• Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study.
• Uncontrolled infectious disease.
• 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.
• A history of severe cardiac dysfunction and/or severe cardiac arrhythmia.
• Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment.
• Pregnancy or lactation, or plans to become pregnant during the study period;
• Any other condition considered by the investigator to make the patient unsuitable for enrollment.