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

Last updated: August 5, 2024
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bronchiectasis

Treatment

AveCure Flexible Microwave Ablation Probe

Clinical Study ID

NCT06105606
23-131
  • Ages 18-80
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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, leftmain stem bronchus), as evidenced by CT or CT/PET imaging confirmed or suspected tobe due to malignant etiology, for which the bronchoscopist has deemed thatendoscopic ablation/debridement is indicated (i.e. endobronchial tumors, mixedendobronchial/extrinsic compression lesions).

Exclusion

Exclusion Criteria:

  • Patients who are unable to understand the informed consent, including potentialrisks 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 thesubject 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.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: AveCure Flexible Microwave Ablation Probe
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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