Study of the AveCure Flexible Microwave Ablation Probe to Treat Lung Nodules Up to 3 cm Using Bronchoscopy Evaluating Safety and Effectiveness in Stage I-II Primary Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of the AveCure Flexible Microwave Ablation Probe for treating cancerous lung nodules up to 3 cm in size in people with Stage I or II primary lung cancer. This pilot study is the first to examine this microwave ablation method using a bronchoscopic approach. The intervention is FDA-approved for this disease and aims to assess its feasibility and efficacy. Participants will undergo the microwave ablation procedure via a bronchoscopic approach guided by Cone Beam Computed Tomography and electromagnetic navigational bronchoscopy. Before ablation, a rapid on-site evaluation will confirm the malignancy of the nodule. After the procedure, a CT scan will check for changes 2 to 4 weeks later, followed by surgery to remove the nodule for pathological examination. Participants will be followed for 30 days post-procedure. During the study, participants will have screening, treatment, and follow-up visits including imaging and tissue evaluations. Researchers will measure the rate of planned ablations and pathological changes in tumor tissue at 4 weeks. Secondary assessments include changes in lung tissue outside the ablation zone and immune-histochemical changes. The total participation time includes the procedure and at least 30 days of follow-up to monitor outcomes and safety.

Avecure Flexible Microwave Ablation Probe For Lung Nodules