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

NCT ID: NCT06105606

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2027-01-31

Brief 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)

Detailed 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.

Conditions

Airway Obstruction; Central Airway Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AvuCure Microwave Ablation

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.

Group Type: EXPERIMENTAL

AveCure Flexible Microwave Ablation Probe

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Avecure 16 Gauge Probe Model 16-123-01-15

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedWaves, Inc

UNKNOWN

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jason A Beattie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Beattie, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason Beattie, MD

Role: CONTACT

jbeattie@bidmc.harvard.edu

617-632-8252

Facility Contacts

Jason Beattie, MD

Role: primary

jbeattie@bidmc.harvard.edu

617-632-8252

Other Identifiers

23-131

Identifier Type: -

Identifier Source: org_study_id