Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
Beth Israel Deaconess Medical Center
10 participants
Mar 8, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria9
- 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.
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Interventions
Consists of a handheld, surgical device which delivers microwave energy from its microwave antenna. The flexible probe has a 3cm active microwave field that radiates from the tip.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06105606