Using Microwave Ablation to Treat Malignant Central Airway Obstructions
Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
This study is testing a new microwave treatment for people with cancer-related airway blockages to see if it can help clear their breathing passages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06105606 on ClinicalTrials.gov |
What this trial studies
This research evaluates the feasibility of the AveCure Microwave Ablation Probe for treating malignant central airway obstructions through a bronchoscopic approach. The study involves a prospective, single-arm cohort design where the probe is applied to the obstruction to deliver microwave energy for tissue destruction. Participants will undergo screening, hospitalization for the procedure, and various assessments including imaging and pulmonary function tests over a period of approximately six months. The study aims to enroll around 10 patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of central airway obstruction due to malignant causes who can undergo bronchoscopy.
Not a fit: Patients who cannot provide informed consent or have contraindications for bronchoscopy under general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive treatment option for patients suffering from malignant central airway obstructions.
How similar studies have performed: While the AveCure Microwave Ablation Probe has FDA approval for general use, its application for central airway obstruction is novel and has not been specifically tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jason Beattie, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Jason Beattie, MD
- Email: jbeattie@bidmc.harvard.edu
- Phone: 617-632-8252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.