Clinical trial NCT06105606: Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
Official title: Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Obstruction
Central Airway Obstruction
Keywords: Endoluminal malignant central airway obstruction
Central airway obstruction
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: MedWaves, Inc
First posted: 2023-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility Failure Rate (FFR)
timeFrame: 6 months
Secondary outcomes:
measure: 6-month airway patency rate
timeFrame: 6 months
measure: Grade 3-5 Treatment-related Toxicity Rate
timeFrame: Adverse events evaluated 1, 3 and 6 month after procedure.
measure: Airway Obstruction (AO) Rate
timeFrame: CT scan at 1, 3, 6 and 12 months after procedure
measure: Change in Subjective Perception of Dyspnea
timeFrame: Assessed 1, 3, 6 and 12 months after procedure.
measure: Number and type of additional tools that are used during bronchoscopy.
timeFrame: Index procedure only (at ablation).
measure: Procedural Bleeding
timeFrame: Index procedure only (at ablation).
measure: Change in peak flow measurement
timeFrame: Baseline to 30 days +/- 7 days post ablation
measure: 6-month Overall Survival (OS)
timeFrame: 6 months
measure: 6-month mechanical ventilation-free survival
timeFrame: 6 months
measure: Histologic characteristics of tissue ablated with the AveCure microwave technology device.
timeFrame: Index procedure only (at ablation).
measure: MW number of energy applications
timeFrame: Index procedure only (at ablation)
measure: MW time of application
timeFrame: Index procedure only (at ablation)
measure: Total time of MW ablation
timeFrame: Index procedure only (at ablation)
measure: Total energy delivered during MW ablation
timeFrame: Index procedure only (at ablation)
measure: Temperature during ablation
timeFrame: Index procedure only (at ablation)
measure: Length of ablation procedure
timeFrame: Index procedure only (at ablation)
measure: Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ)
timeFrame: ssessed 1, 3, 6 and 12 months after procedure.
measure: Procedural bleeding
timeFrame: Index procedure only (at ablation)
measure: Change in Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30)
timeFrame: Assessed 1, 3, 6 and 12 months after procedure.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jason Beattie, MD
role: PRINCIPAL_INVESTIGATOR
References: