Avecure Flexible Microwave Ablation Probe For Lung Nodules

Study Overview
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Brief Summary
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This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size. This research study involves microwave ablation (MWA)

Detailed Description
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This will be a single arm, prospective cohort study. The names of the study intervention involved in this study is: Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA) A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive the study intervention and will be followed for 30 days. It is expected that about 10 people will take part in this research study. This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules. The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Official Title
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Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule

Conditions
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Stage I - II Primary Lung Cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer

Intervention / Treatment
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* Device: AveCure 16 Gauge Flexible Microwave Ablation Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE. Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively Resection/surgical candidate (lobectomy or greater) Participants must be at least 22 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 another electronic implantable device Patient cannot tolerate bronchoscopy Patients with coagulopathy Patients in other therapeutic lung cancer studies Subject is pregnant or breastfeeding COVID-19 positive patient at the time of procedure.

Ages Eligible for Study
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Minimum Age: 22 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: AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES<br>The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm. CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure. Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology. | Device: AveCure 16 Gauge Flexible Microwave Ablation Probe<br>* Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery<br>* Other names: Avecure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Planned Ablations. | Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol. | Day 1 | 
| Pathological changes in the tumor tissue. | Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological changes in lung tissue outside the zone of predicted ablation. | A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described. | 4 weeks | 
| Immune-histochemical changes in the tumor tissue. | Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage I - II primary lung cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II, Lung Cancer