A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects with Oligometastatic Tumors in the Lung

The primary objective of the study is to evaluate the safety and effectiveness of the NEUWAVETM FLEX MC Microwave Ablation System and Accessories used in transbronchial ablation procedures for adult subjects with oligometastatic tumors ( 2cm) in the lung. Technique Efficacy: Ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) using CT imaging at 30 days (-7 to +14 days) post the original ablation procedure. Technical Success: All A0 and A1 ablation classification determinations (complete tumor ablation with a surrounding minimal margin) as assessed by cone beam CT imaging, immediately following the ablation procedure. Navigational Success: Successful navigation to the targeted peripheral lung tumor(s) as confirmed using cone beam CT (CBCT). Local Tumor Progression (LTP): Recurrence of originally ablated target tumor(s) within or abutting the ablation zone using 30-day post-ablation imaging as the baseline. Local Tumor Progression Free Survival (LTPFS): Time from the ablation until local tumor(s) progression (LTP) or death, whichever occurs first. Progression Free Survival: Time from the original ablation until tumor(s) progression or death, whichever occurs first (includes local, regional, or distant progression). Disease (cancer) Specific Survival: Time from the original ablation until death from the treated primary malignancy. Overall Survival: Time from the original ablation until subject death (includes death from any cause). Repeat Ablation Efficacy Rate: Rate of original tumors that have been re-ablated successfully (i.e., Technical Success of tumors that have been re-ablated/all original tumors that have been re-ablated). Change in all available PFTs (pulmonary function tests) from pre-ablation baseline values to values at 3 months, 6 months, and 12 months post-ablation. Change in overall health-related quality of life (HRQOL) and sub-scales, including physical functioning and pain domains, per the validated EORTC QLQ-C30 and QLQ-LC13 questionnaires throughout the duration of the study.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All