Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Study Overview
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Brief Summary
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Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.

Detailed Description
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This study is a prospective, single-arm, single-center, study to evaluate the safety and technical feasibility of using the phenoWave MW Ablation System to deliver microwave energy for ablation of lesions in the lung.

Official Title
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Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Device: Flexible Bronchoscopic Microwave Ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible Microwave Ablation<br>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. | Device: Flexible Bronchoscopic Microwave Ablation<br>* The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - AE occurrence | Incidence of complications and occurrence of Adverse Events (AEs) | up to 7 days post ablation | 
| Safety - AE frequency | Frequency of AEs | up to 7 days post ablation | 
| Safety - ablated tissue assessment | Percentage of ablated tissue within tumor boundary as assessed on gross and/or histologic evaluation | up to 7 days post ablation | 
| Technical Feasibility | Evidence of thermal ablation in portion of the tumor as assessed on histopathology | up to 7 days post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigational Success | Measured distance of phenoWave device tip relative to the planned position from CT data | Immediately after completion of procedure (day 0) | 
| Procedural Measures | Total procedure time and navigation time to position the device | Immediately after completion of procedure and navigation to the target (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flexperc medical, microwave, ablation, phenoWave, phenoMapper