Observational Study on the Use of HistoSonics Edison System for Liver Tumor Treatment Including Long-Term Follow-Up

What this Trial Is About

This research aims to collect information on the use of the HistoSonics Edison System, a device used for histotripsy treatment of liver tumors. The study is observational and seeks to understand how different patient and procedural factors may influence treatment success measured within 36 hours after the procedure. It also includes sub-studies focusing on specific patient groups or clinical questions with more detailed follow-up. Participants receive histotripsy treatment with the HistoSonics Edison System to partially or completely destroy liver tumors. The study does not dictate specific treatment plans but collects real-world data on how the system is used by different physicians across various clinical settings. Participants may also join sub-studies with stricter criteria alongside the main study. Throughout the study, participants are followed according to standard clinical care for up to 5 years or until their sub-study follow-up ends. Imaging is performed within 36 hours after treatment to assess success. Researchers review adverse event data regularly and gather information before, during, and after treatment to evaluate outcomes and monitor safety over time.

Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)