Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung

Study Overview
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Brief Summary
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A post-market study to assess the performance and safety of a RF ablation catheter to bronchoscopically ablate lung lesions will be evaluated in patients with confirmed diagnosis of non-small cell lung cancer or metastatic lung lesions who are scheduled for surgical resection.

Detailed Description
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This study is a prospective, single-arm, multi-center, post-market study of bronchoscopic radio frequency (RF) ablation treatment malignant lung lesions prior to surgical resection. Up to 15 patients will be treated at the participating sites. Patients identified for the study will have been scheduled for surgical resection as part of their treatment for lung lesions. The RF ablation procedure will be performed during a standard-of-care bronchoscopic procedure at minimum of 24 hours prior to resection. The patients exits the study following surgical resection. The resected tissue will undergo pathological evaluation for tissue viability.

Official Title
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Post-Market Optimization Study of the EMPOWER® RF Catheter to Ablate Soft Tissue Lesions in the Lung

Conditions
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Lung Diseases

Intervention / Treatment
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* Device: Radiofrequency (RF) catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at screening Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor Eligible for standard of practice lung resection (pneumonectomy, lobectomy) Tumor/lesion > 2cm along the major diameter with no visible necrosis Signed informed consent form Exclusion Criteria: An implantable pacemaker, defibrillator, or other active implants Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RF ablation

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roll-in<br>Initial patients enrolled until optimal RF algorithm is determined | Device: Radiofrequency (RF) catheter<br>* A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation<br>* Other names: EMPOWER® RF Catheter;|
| Optimized<br>Patients treated using optimal RF algorithm | Device: Radiofrequency (RF) catheter<br>* A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation<br>* Other names: EMPOWER® RF Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance - maximum diameter of zone of thermal necrosis surrounding treated lesion | Maximum diameter (in mm) of ablation zone (thermal necrosis) surrounding treated lesion as measured in resected tissue by quantitative histopathological and gross pathological analysis | The interval between ablation and tissue resection for pathological analysis is a minimum of 24 hours, but the exact interval depends on the investigator's standard of care | 
| Performance - ability of the user and device to deliver ablative treatment in accordance with the catheter's Instructions for Use | The ability of the ablation treatment to be delivered as per the Instructions for Use will be assessed using a binary categorical scale (yes/no) | Assessed at the time of the RF ablation procedure | 
| Safety - Adverse events (AEs) and serious adverse events (SAEs) | The incidence of reported adverse events and serious adverse events related to the RF ablation procedure/device | AEs and SAEs related to the RF procedure/device will be reported for the interval beginning with the RF ablation procedure and ending with the surgical resection of the ablated lung tissueion |