NEUWAVE Flexible Probe Study #2

Study Overview
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Brief Summary
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Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.

Detailed Description
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Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.

Official Title
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A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung

Conditions
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Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma

Intervention / Treatment
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* Device: Microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Patients greater or equal to 18 years of age Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG]) Willing to fulfill all follow-up visit requirements Medically inoperable and operable secondary soft tissue lesion(s) of the lung A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging. Exclusion Criteria: Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related Pregnant or breastfeeding Physical or psychological condition that would impair study participation Patients with uncorrectable coagulopathy at the time of screening Patient with implantable devices, including pacemakers or other electronic implants Prior pneumonectomy or bronchiectasis Severe neuromuscular disease Patient count less than or equal to 50,000/mm cubed ASA (American Society of Anesthesiologists) score of greater than or equal to 4 Inability to tolerate anesthesia Expected survival less than 6 months Clinically significant hypertension Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions (however, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted) Endobronchial soft tissue lesions proximal to the segmental airways Imaging findings of active pulmonary infection The patient was judged unsuitable for study participation by the Investigator for any other reason.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microwave Ablation<br>Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon. | Device: Microwave ablation<br>* Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device User Experience Survey | The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device. | Day of ablation (day 0) | 
| Technical Success (lesion completely ablated) | Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure. | Day of ablation (day 0) | 
| Technique Efficacy (lesion completely ablated) | Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation). | 30 days post-ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Any AEs attributable to the ablation procedure, including all device-related, procedure-related, and SAEs, evaluated from the start of the ablation procedure throughout the entirety of the study (i.e. through 1 year post-ablation). | 1 year post-ablation | 
| Primary Efficacy Rate | The Primary Efficacy Rate is the percentage of target lesions successfully eradicated following the first ablation procedure, as assessed using CT imaging by the treating physician on the day of ablation. | Day of ablation (day 0) | 
| Secondary Efficacy Rate | The Secondary Efficacy Rate is defined as the percentage of soft tissue lesions that have undergone successful repeat ablations following identification of local soft tissue lesions progression, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. 1 year post-ablation). | 1 year post-ablation | 
| Target Lesion Recurrence | Target Lesion Recurrence is defined as the reappearance of the lesion(s) at the treated site, as assessed using CT imaging by the treating physician throughout the entirety of the study (i.e. through 1 year post-ablation). | 1 year post-ablation | 
| Length of Hospital Stay | The Length of Hospital Stay is defined as the length of time of hospitalization from the end of the ablation procedure to the time of discharge (up to 23 hours post-ablation). | Day of ablation (day 0) | 
| Hospital Readmission Rate | The Hospital Readmission Rate is defined as the percentage of patients who were readmitted to the hospital within 30 days of the ablation procedure. | 30 days post-ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microwave Ablation