Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule
Beth Israel Deaconess Medical Center
Summary
This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size. This research study involves microwave ablation (MWA)
Description
This will be a single arm, prospective cohort study. The names of the study intervention involved in this study is: * Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA) * A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will receive the study intervention and wi…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE. * Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards * Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively * Resection/surgical candidate (lobectomy or greater) * Participants must be at least 22 years old and able to provide consent Exclusion Criteria: * Subjects in whom flexible broncho…
Interventions
- DeviceAveCure 16 Gauge Flexible Microwave Ablation Probe
Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts