Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Bronchoscopy With Subsequent Surgical Resection

The purpose of this study is to confirm the procedural feasibility and device usability of the HybridTherm® system during bronchoscopic cryo-assisted radiofrequency ablation (RFA) performed prior to scheduled surgical resection in patients with lung cancer. The bronchoscopy session includes tumor ablation and, when clinically indicated, mediastinal lymph node staging by EBUS-TBNA.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Patients who require diagnostic bronchoscopy for suspicious lung lesions with mediastinal lymph node status confirmed as NO by one of the following: Prior PET-CT showing no FDG-avid mediastinal lymph nodes, OR intraoperative EBUS-TBNA with ROSE confirming negative lymph nodes (performed when clinically indicated per section 6.1).
* Solitary pulmonary lesions ≤ 2.5cm with histologically or cytologically confirmed primary lung cancer.
* Suitable candidate for surgical resection of the tumor targeted for ablation
* Interdisciplinary tumor board consent
* Ability to read, understand, and sign patient Informed Consent Form (ICF)
* Age ≥ 18-years-old
* ≥ 20 mm of free space between the calculated intended ablation zone and the lung parenchyma or any critical structures (pleura, vessels and main bronchi).

Exclusion Criteria:

* Pregnant or nursing (breast feeding) females
* Central tumors abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea)
* Thoracic electronic implants (e.g., pacemakers, ICDs)
* Uncorrectable coagulopathy or platelet count ≤ 50,000/mm³
* Patients receiving anticoagulant therapy or with pulmonary hypertension that, in the opinion of the Investigator, poses an unacceptable safety risk for bronchoscopy and ablation.
* Severe, uncontrolled comorbidities
* Active systemic infection
* Prior radiation therapy (SBRT) in the intended ablation zone
* Recent Investigational therapy within the last 30 days that the investigator deems could interfere with proceeding in the clinical investigation
* Tumors associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis
* Investigators determine that study participation poses safety risk
* Any comorbidities judged by the principal Investigator to be contraindicated for bronchoscopy
* Subject was judged unsuitable for study participation by the Investigator for any other reason

• BACKGROUNDSignoretti M, Valente R, Repici A, Delle Fave G, Capurso G, Carrara S. Endoscopy-guided ablation of pancreatic lesions: Technical possibilities and clinical outlook. World J Gastrointest Endosc. 2017 Feb 16;9(2):41-54. doi: 10.4253/wjge.v9.i2.41. PMID 28250896
• BACKGROUNDDabizzi E, Testoni SG, Barbera M et al. 484 EUS-GUIDED CRYOTHERM ABLATION OF STAGE III PANCREATIC ADENOCARCINOMA: A PRELIMINARY RADIOLOGICAL PERSPECTIVE. Gastrointest Endosc 2018; 87: AB84
• BACKGROUNDTestoni SGG, Petrone MC, Reni M, Di Serio C, Rancoita PM, Rossi G, Balzano G, Linzenbold W, Enderle M, Della-Torre E, De Cobelli F, Falconi M, Capurso G, Arcidiacono PG. EUS-guided ablation with the HybridTherm Probe as second-line treatment in patients with locally advanced pancreatic ductal adenocarcinoma: A case-control study. Endosc Ultrasound. 2022 Sep-Oct;11(5):383-392. doi: 10.4103/EUS-D-21-00200. PMID 36255026
• BACKGROUNDTestoni SGG, Petrone MC, Reni M, Rossi G, Barbera M, Nicoletti V, Gusmini S, Balzano G, Linzenbold W, Enderle M, Della-Torre E, De Cobelli F, Doglioni C, Falconi M, Capurso G, Arcidiacono PG. Efficacy of Endoscopic Ultrasound-Guided Ablation with the HybridTherm Probe in Locally Advanced or Borderline Resectable Pancreatic Cancer: A Phase II Randomized Controlled Trial. Cancers (Basel). 2021 Sep 8;13(18):4512. doi: 10.3390/cancers13184512. PMID 34572743
• BACKGROUNDArcidiacono PG, Carrara S, Reni M, Petrone MC, Cappio S, Balzano G, Boemo C, Cereda S, Nicoletti R, Enderle MD, Neugebauer A, von Renteln D, Eickhoff A, Testoni PA. Feasibility and safety of EUS-guided cryothermal ablation in patients with locally advanced pancreatic cancer. Gastrointest Endosc. 2012 Dec;76(6):1142-51. doi: 10.1016/j.gie.2012.08.006. Epub 2012 Sep 26. PMID 23021160
• BACKGROUNDAhmed M, Liu Z, Afzal KS, Weeks D, Lobo SM, Kruskal JB, Lenkinski RE, Goldberg SN. Radiofrequency ablation: effect of surrounding tissue composition on coagulation necrosis in a canine tumor model. Radiology. 2004 Mar;230(3):761-7. doi: 10.1148/radiol.2303021801.