General Description of Study Clause Samples
General Description of Study. After consent and evaluation of all inclusion and exclusion criteria, subjects will be enrolled in the study. The subject will undergo standard pre-operative testing, per the study institutional requirements. At that time, subject ▇▇▇▇▇ ▇▇▇▇▇ will be recorded. The subject will be prepped for bronchoscopy. A pre-ablation chest CT will be taken. The target nodule/tumor will be accessed via EBUS bronchoscopy and ablated using the ANET Electrosurgical Applicator. Following ablation, there will be a bronchoscopic exam of the treated region and a repeat chest CT will be taken. Immediately following bronchoscopy and ablation of the target tissue, the subject will undergo the planned surgical resection. The ablated tumor will be prepared for histopathological and may be prepared for immunohistochemistry evaluation to assess the area of ablated tissue. Subjects will be followed peri-operatively. There is no long-term follow-up since the ablated tissue will be resected during the surgical procedure, however adverse events will be captured through 30 days post procedure. Blood will be drawn pre and post-ablation and 2-4 weeks post-surgery to evaluate for potential immune response indicators. 6 SUBJECT POPULATION Adult subjects with confirmed Stage I or Stage II primary lung cancer or metastatic lung tumor with a pulmonary nodule/tumor suitable for ablation, by the ANET device via EBUS bronchoscopy, prior to planned surgical resection.
General Description of Study. After consent and evaluation of all inclusion and exclusion criteria, subjects will be enrolled in the study. The subject will undergo standard pre-operative testing, per the study institutional requirements. At that time, subject ▇▇▇▇▇ ▇▇▇▇▇ will be recorded. The subject will be prepped for bronchoscopy. A pre-ablation chest CT will be taken. The target nodule/tumor will be accessed via EBUS bronchoscopy, which may be guided and confirmed with Cone Beam CT, Intra-operative CT, or fluoroscopy, and ablated using the ANET Electrosurgical Applicator. Following ablation, there will be a bronchoscopic exam of the treated region and repeat chest CT will be taken. Immediately following bronchoscopy and ablation of the target tissue, the subject will undergo the planned surgical resection. The ablated tumor will be prepared for histopathological and immuno-histochemistry evaluation to assess the area of ablated tissue. Subjects will be followed peri-operatively. There is no long-term follow-up since the ablated tissue will be resected during the surgical procedure, however adverse events will be captured through 30 days post procedure. Blood will be drawn pre and post-ablation and 2-4 weeks post-surgery, per the ANET Blood Draw Lab Manual, DN0042775, to evaluate for potential immune response indicators. Blood specimens will be analyzed by a core laboratory to characterize cells important in immune responses and the disease process.
