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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System
Timeframe: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
Number of Participants with Bleeding-Related Serious Adverse Events Associated with the Investigational Device and/or RFA Procedure
Timeframe: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Severity of Bleeding-Related Adverse Events as Assessed by the Nashville Bleeding Scale
Timeframe: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Dr. Carolin Steinack, Head of Interventional Pulmonology