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

Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105606
• Other study ID #: 23-131
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: January 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Jason Beattie, MD
• Phone: 617-632-8252
• Email: jbeattie[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• AveCure Flexible Microwave Ablation Probe
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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	MedWaves, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Number and type of additional tools that are used during bronchoscopy.		Index procedure only (at ablation).
Secondary	Procedural Bleeding	bleeding assessed by the Nashville scale	Index procedure only (at ablation).
Secondary	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
Secondary	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
Secondary	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
Secondary	Histologic characteristics of tissue ablated with the AveCure microwave technology device.		Index procedure only (at ablation).
Secondary	MW number of energy applications		Index procedure only (at ablation)
Secondary	MW time of application	seconds	Index procedure only (at ablation)
Secondary	Total time of MW ablation	seconds	Index procedure only (at ablation)
Secondary	Total energy delivered during MW ablation	mW	Index procedure only (at ablation)
Secondary	Temperature during ablation	degrees Celsius	Index procedure only (at ablation)
Secondary	Length of ablation procedure	minutes	Index procedure only (at ablation)
Secondary	Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ)		ssessed 1, 3, 6 and 12 months after procedure.
Secondary	Procedural bleeding	estimated blood loss (mL)	Index procedure only (at ablation)
Secondary	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.