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Recruiting NCT06105606

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

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Trial Parameters

Condition Airway Obstruction
Sponsor Beth Israel Deaconess Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-03-08
Completion 2025-01-31
Interventions
AveCure Flexible Microwave Ablation Probe

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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)

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 othe

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