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

NCT06105606 | Terminated DMC FDA Device

• 1 other identifier: 23-131
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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)

Conditions

Airway Obstruction; Central Airway Obstruction

Keywords

Endoluminal malignant central airway obstruction; Central airway obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 6-month airway patency rate

  6 months

• Grade 3-5 Treatment-related Toxicity Rate

  Adverse events evaluated 1, 3 and 6 month after procedure.

• Airway Obstruction (AO) Rate

  CT scan at 1, 3, 6 and 12 months after procedure

• Change in Subjective Perception of Dyspnea

  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).

Study Arms (1)

AvuCure Microwave Ablation

EXPERIMENTAL

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

Interventions

AveCure Flexible Microwave Ablation Probe 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.

Also known as: Avecure 16 Gauge Probe Model 16-123-01-15

AvuCure Microwave Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jason Beattie, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: October 27, 2023
• Study Start: March 8, 2024
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)