Clinical trial · Interventional
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
NCT06158971CI-TRIAL-00075717unknownN/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)
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
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 Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexible Bronchoscopic Microwave Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Flexible Microwave Ablation
- description
- Soft tissue ablation will be performed using the phenoWave flexible Microwave Ablation System and Accessories on lesions in the peripheral lung. The image-guided ablation procedure may utilize a combination of the radial EBUS and conebeam CT to confirm the lesion, position of the device relative to lesion and monitor the ablation progress.
- interventionNames
- Device: Flexible Bronchoscopic Microwave Ablation
Primary outcomes (4)
- measure
- Safety - AE occurrence
- timeFrame
- up to 7 days post ablation
- description
- Incidence of complications and occurrence of Adverse Events (AEs)
- measure
- Safety - AE frequency
- timeFrame
- up to 7 days post ablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 77 Years
Show eligibility criteria text
Inclusion Criteria: * Age 45-77 years at screening. * Confirmed NSCLC or solitary metastatic (oligometastatic) or pulmonary metastases from an extra thoracic primary tumor lung nodule through diagnostic biopsy * Must be eligible for curative lung resection (lobectomy). * For primary tumor, pre-ablated parenchymal tumor/lesion size ≥ 20 mm if NSCLC, or ≥ 10 mm for metastatic disease in diameter as measured from pre-operative CT image. * Willing to participate in all aspects of study protocol for duration of study. * Able to understand study requirements. * Signs informed consent form. * Boundary of tumor is at least 15 mm away from the pleura wall and/or fissure. 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. * Uncorrectable coagulopathy. * Known coagulopathy. * Platelet dysfunction or platelet count \< 100 x 109 cells/L OR taking anticoagulant or antiplatelet agents that cannot be safely ceased in the opinion of the pulmonologist or surgeon. * History of major bleeding with bronchoscopy. * Suspected pulmonary hypertension. * Moderate-to-severe pulmonary fibrosis. * Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD) within 3cm of tumor/lesion boundary: prior COPD assessment data is evaluated and PI consent is required. * Bullae \>5 centimeter (cm) located in vicinity of target tumor/lesion. * Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic MWA, for example: * American Society of Anesthesiologists (ASA) physical status classification \>P3 * Stage 3 heart failure * Severe cachexia * Severe respiratory insufficiency or hypoxia * Ongoing systemic infection. * Contraindication to general anesthesia. * Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure. * Participation in any other study in last 30 days. * 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 6 months. * Prior radiation therapy treatment in the target lobe. * Implantable pacemaker or defibrillator.
References
Publications (0)
Data not yet available
No reference posted for this study.