Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions

Study Overview
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Brief Summary
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This research is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of malignant central airway obstruction using a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic). The name of the intervention being used in this research study is: AveCure Flexible Microwave Ablation Probe (handheld, surgical device that delivers microwave energy via flexible probe tip)

Detailed Description
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This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of malignant lesions causing central airway obstructions (COA). The AveCure prob will be placed in contact with the COA to treat with energy. The U.S. Food and Drug Administration (FDA) has approved this intervention for use throughout the body, but it has not been approved for the specific indication of central airway obstruction. Research study procedures include screening for eligibility, hospitalization for bronchoscopy and MWA, blood tests, survey questionnaires, Computerized Tomography (CT) scan imaging, and pulmonary function tests. Participation in this research study is expected to last about 6 months. It is expected that about 10 people will take part in this research study. MedWaves, Inc is funding this research study by providing the ablation probe and generator.

Official Title
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Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions

Conditions
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Airway Obstruction, Central Airway Obstruction

Intervention / Treatment
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* Device: AveCure Flexible Microwave Ablation Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age between 18 and 80 years of age and able to provide informed consent. Candidate for bronchoscopy under general anesthesia. Diagnosis of central airway obstruction (trachea, right main stem bronchus, left main stem bronchus), as evidenced by CT or CT/PET imaging confirmed or suspected to be due to malignant etiology, for which the bronchoscopist has deemed that endoscopic ablation/debridement is indicated (i.e. endobronchial tumors, mixed endobronchial/extrinsic compression lesions). Exclusion Criteria: Patients who are unable to understand the informed consent, including potential risks and benefits of the procedure. Patients in whom bronchoscopy under general anesthesia is contraindicated. 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 Patients with coagulopathy Patients in other therapeutic lung cancer studies COVID-19 positive patient at the time of the procedure. Patients who are pregnant Patients with purely extrinsic compression of the airway.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: AvuCure Microwave Ablation<br>Participants will undergo study procedures as follows: Baseline assessments Hospital admission for bronchoscopy under general anesthesia and microwave ablation via standard of care. Participants will be followed at 1, 3, and 6 months post-procedure. | Device: AveCure Flexible Microwave Ablation Probe<br>* Consists of a handheld, surgical device which delivers microwave energy from its microwave antenna. The flexible probe has a 3cm active microwave field that radiates from the tip.<br>* Other names: Avecure 16 Gauge Probe Model 16-123-01-15;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility Failure Rate (FFR) | Feasibility of the AveCure microwave technology to ablate a target malignant central and lobar airway lesions causing > 50% obstruction, defined as at least 9/10 of the planned ablations (90%) successfully performed bronchoscopically according to the study protocol | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month airway patency rate | 6-month airway patency rate defined as the proportion of participants achieve airway patency. Airway patency will be calculated as the minimal airway luminal area at the CAO as a percentage of the average of the distal and proximal airway luminal areas. | 6 months | 
| Grade 3-5 Treatment-related Toxicity Rate | All grade 3-5 adverse events (AE) with attribution of possibly, probably or definitely related to neoadjuvant treatment based on CTCAEv5 are counted. Rate is the proportion of treated participants with at least one post-baseline safety assessment experiencing at least one of these adverse events during the time of observation. | Adverse events evaluated 1, 3 and 6 month after procedure. | 
| Airway Obstruction (AO) Rate | AO Rate defined as percentage of airway obstruction assessed at bronchoscopy and on CT scan after the study procedure measured through the Myer-Cotton grading system and percentage change in luminal cross sectional area. Central airway obstruction (CAO) is defined as occlusion of more than 50% of the trachea, mainstem bronchi, bronchus intermedius, or a lobar bronchus. | CT scan at 1, 3, 6 and 12 months after procedure | 
| Change in Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) |  | Assessed 1, 3, 6 and 12 months after procedure. | 
| Change in Subjective Perception of Dyspnea | subjective perception of dyspnea as measured by the modified Medical Research Council dyspnea scale (mMRC) | Assessed 1, 3, 6 and 12 months after procedure. | 
| Number and type of additional tools that are used during bronchoscopy. |  | Index procedure only (at ablation). | 
| Procedural Bleeding | bleeding assessed by the Nashville scale | Index procedure only (at ablation). | 
| Change in peak flow measurement | Peak flow measurement using a standard peak flow meter will also be performed by research staff. | Baseline to 30 days +/- 7 days post ablation | 
| 6-month Overall Survival (OS) | 6-month OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive. | 6 months | 
| 6-month mechanical ventilation-free survival | 6-month mechanical ventilation-free survival is a probability estimated using the Kaplan Meier method; PFS is defined as the duration of time from study entry to documented mechanical ventilation. | 6 months | 
| Histologic characteristics of tissue ablated with the AveCure microwave technology device. |  | Index procedure only (at ablation). | 
| MW number of energy applications |  | Index procedure only (at ablation) | 
| MW time of application | seconds | Index procedure only (at ablation) | 
| Total time of MW ablation | seconds | Index procedure only (at ablation) | 
| Total energy delivered during MW ablation | mW | Index procedure only (at ablation) | 
| Temperature during ablation | degrees Celsius | Index procedure only (at ablation) | 
| Length of ablation procedure | minutes | Index procedure only (at ablation) | 
| Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ) |  | ssessed 1, 3, 6 and 12 months after procedure. | 
| Procedural bleeding | estimated blood loss (mL) | Index procedure only (at ablation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoluminal malignant central airway obstruction, Central airway obstruction