ANET Electrosurgery Applicator Pilot Evaluation Study

Study Overview
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Brief Summary
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Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

Detailed Description
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This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects. Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.

Official Title
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ANET Electrosurgery Applicator Pilot Evaluation Study

Conditions
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Lung Cancer, Lung Cancer Metastatic

Intervention / Treatment
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* Device: RF Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor Pathological proof of target nodule/tumor type and malignancy Target nodule/tumor which can be accessed via EBUS bronchoscopy Resection/surgical candidate Participants must be at least 18 years old and able to provide consent Exclusion criteria: Subjects in whom flexible bronchoscopy is contraindicated Target nodule < 1.0 cm Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives Pacemaker, implantable cardioverter, or other electronic implantable device

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RF Ablation<br>Single-arm study where subjects receive RF ablation prior to a scheduled surgical resection. | Device: RF Ablation<br>* The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANET Related Peri-procedural Adverse Events | The incidence of reported adverse events and serious adverse events related to the ANET device or procedure | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrosurgery, RF ablation, Minimally invasive, Lung cancer, Lung metastasis, Lung tumor, Primary, Metastatic, Endobronchial ultrasound, EBUS