Avecure Flexible Microwave Ablation Probe For Lung Nodules
United States10 participantsStarted 2022-06-01
Plain-language 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)
Who can participate
Age range22 Years
SexALL
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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 bronchoscopy is contraindicated
* Target nodule \< 1.0 cm
* Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
* 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
* Patient cannot tolerate bronchoscopy
* Patients with coagulopathy
* Patients in other therapeutic lung cancer studies
* Subject is pregnant or breastfeeding
* COVID-19 positive patient at the time of procedure.