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NCT07830095
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
Conditions: Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Shanghai Chest Hospital
Location: Shanghai Chest Hospital Shanghai
Summary
The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years.
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
4. Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.
5. Determined to be unsuitable for or unwilling to undergo antitumor drug therapy.
6. Considered technically feasible for robotic-assisted bronchoscopy-guided cryoablation of the target lesion(s).
7. Provided written informed consent after being fully informed of the study procedures, potential benefits, and risks.
Exclusion Criteria:
1. Unable to tolerate or unwilling to undergo general anesthesia.
2. Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.
3. Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.
4. 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.
5. Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count \18 s, or prothrombin activity \
Source: ClinicalTrials.gov (NCT07830095). StuddyBuddy aggregates publicly available trial information.