Status:
RECRUITING
Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
MedWaves, Inc
Conditions:
Airway Obstruction
Central Airway Obstruction
Eligibility:
All Genders
18-80 years
Phase:
NA
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,...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06105606
Start Date
March 8 2024
End Date
January 31 2027
Last Update
August 6 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215