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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Oct 26, 2023

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ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with malignant central airway obstructions, which occur when tumors block the airways. The study is testing a device called the AveCure Flexible Microwave Ablation Probe, which uses microwave energy to destroy the obstructing tissue. This procedure is performed through a thin tube inserted into the airway, allowing doctors to view and treat the blockage safely.

To be eligible for the trial, participants must be between 18 and 80 years old and able to give informed consent. They should also be candidates for a procedure called bronchoscopy, which is done under general anesthesia, to treat central airway obstructions caused by cancer. However, certain individuals, such as those with specific health conditions or those who are pregnant, may not be able to participate. If you join the study, you can expect close monitoring and support from the medical team as they assess the safety and effectiveness of this new treatment.

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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.