Clinical trial · Interventional
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)
NCT07830095CI-TRIAL-00126497not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with pulmonary malignancies
- description
- 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.
- interventionNames
- Procedure: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation
Primary outcomes (1)
- measure
- Technical Success Rate (Lesion Level)
- timeFrame
- Immediately after procedure
- description
- 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.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \<50 × 10\^9/L, prothrombin time \>18 s, or prothrombin activity \<40%. 6. Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure. 7. Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study. 8. Uncontrolled infectious disease. 9. 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. 10. Acute cardiovascular or cerebrovascular events, such as acute ischemic stroke or acute coronary syndrome, within 3 months before enrollment. 11. A history of severe cardiac dysfunction and/or severe cardiac arrhythmia. 12. Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment. 13. Pregnancy or lactation, or plans to become pregnant during the study period; 14. Any other condition considered by the investigator to make the patient unsuitable for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.