Clinical trial · Interventional
Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors
NCT03272971CI-TRIAL-00041413terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.
Conditions
Conditions (3)
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 |
| Lung Cancer Metastatic | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radio-frequency Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radio-frequency Ablation
- description
- Single-arm study where subjects receive radio-frequency ablation prior to a scheduled, surgical resection.
- interventionNames
- Device: Radio-frequency Ablation
Primary outcomes (3)
- measure
- RFA relate AEs/SAEs
- timeFrame
- Day 0
- description
- The incidence of reported adverse events and serious adverse events related to the RFA procedure
- measure
- Feasibility - Ablated Tissue
- timeFrame
- Day 0
- description
- Semi-quantitative scoring of necrotic tissue assessed by histology
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor * Must be eligible for curative lung resection (lobectomy) * Tumor/lesion size will be a minimum of 10mm along the minor diameter * Willing to participate in all aspects of study protocol for duration of the study * Able to understand study requirements * Signs informed consent form Exclusion Criteria: * Any contraindication to bronchoscopy, for example: * Untreatable life-threatening arrhythmias. * Inability to adequately oxygenate the patient during the procedure. * Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated). * Recent myocardial infarction. * Previously diagnosed high-grade tracheal obstruction. * Uncorrectable coagulopathy * Known coagulopathy * Platelet dysfunction or platelet count \<100 x 10\^3 cells/mm3 * History of major bleeding with bronchoscopy * Suspected pulmonary hypertension: additional testing required, such as ECG * Moderate-to-severe pulmonary fibrosis * Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD): additional testing and PI consent is required * Bullae \>5cm located within the same lobe of target tumor/lesion * Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RFA * Ongoing systemic infection * Contraindications to general anesthesia * Inability to stop anticoagulants or antiplatelet agents prior to procedure as dictated by the protocol * Prior thoracic surgery on the same side of the lung as the targeted tumor/lesion * Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study * Life expectancy of less than one year.
References
Publications (0)
Data not yet available
No reference posted for this study.