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

Beth Israel Deaconess Medical Center10 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Airway Obstruction

Interventions

AveCure Flexible Microwave Ablation ProbeDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: CT scan at 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)

Time frame: Assessed 1, 3, 6 and 12 months after procedure.

Number and type of additional tools that are used during bronchoscopy.

Time frame: Index procedure only (at ablation).

Procedural Bleeding

bleeding assessed by the Nashville scale

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Histologic characteristics of tissue ablated with the AveCure microwave technology device.

Time frame: Index procedure only (at ablation).

MW number of energy applications