Clinical trial · Interventional
Robotic-Assisted Bronchoscopy-Guided Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules
A Feasibility Study on Synchronous Biopsy and Radiofrequency Ablation for Pulmonary Nodules Under Robotic-Assisted Bronchoscopy: A Prospective, Single-Arm, Open-Label Clinical Study：ROBUST Study
NCT07545057CI-TRIAL-00109594not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single-arm, open-label clinical study. The primary study objective is to evaluate the feasibility of synchronous biopsy and radiofrequency ablation for pulmonary nodules under robotic-assisted bronchoscopy.
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 |
|---|---|---|---|
| Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with clinically suspected malignant pulmonary nodules requiring diagnosis and treatment
- interventionNames
- Procedure: Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules
Primary outcomes (1)
- measure
- Technical success rate (at the lesion level)
- timeFrame
- 6 months
- description
- The proportion of lesions with a definite malignant diagnosis by synchronous biopsy and effective ablation (with postoperative immediate imaging indicating that the ablation range is at least 5 mm larger than the boundary of the target lesion) among the lesions ultimately diagnosed as malignant.
Secondary outcomes (8)
- measure
- Biopsy diagnostic yield (at the lesion level)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old; * Chest CT indicates pulmonary nodules, highly suspected of being malignant; * Size of pulmonary nodules: 8 mm \< maximum diameter ≤ 30 mm, and the number of pulmonary nodules requiring intervention ≤ 3; * Preoperative imaging evaluation indicates no clear lymph node metastasis or distant metastasis (cT1N0M0); * Multidisciplinary evaluation shows that the patient cannot tolerate surgery and radiotherapy, or the patient refuses surgery and radiotherapy after full informed consent; * The patient understands and agrees to receive synchronous biopsy and ablation treatment under robotic-assisted bronchoscopy and signs a written informed consent form. Exclusion Criteria: * Patients who cannot tolerate general anesthesia due to advanced age or severe cardiopulmonary diseases, or other reasons; * The target nodule has been diagnosed as a malignant tumor or metastasis; * Patients with severe bleeding tendency or uncorrectable coagulation disorder (platelet count \< 50×10\^9 /L, prothrombin time \> 18s, prothrombin activity \< 40%); * Severe pulmonary fibrosis and pulmonary hypertension; * Anticoagulant or anti-platelet drugs have not been discontinued for the required time before surgery; * Implanted cardiac pacemaker, defibrillator, or other electronic implants; * Presence of important blood vessels that cannot be avoided along the biopsy path; * Other conditions that the investigators consider not suitable for the patient to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.