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

The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure. Sub-studies to the BOOMBOX: Master Study will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any participant enrolled in the BOOMBOX: Master Study that also qualifies for a sub-study may enroll in the sub-study in parallel; sub-studies will be described in separate sub-study protocols. The BOOMBOX: Master Study will collect information about participants before, during, and after the histotripsy treatment procedure. All participants will be followed per standard clinical follow-up based on each site's clinical practice for up to 5 years after the initial histotripsy procedure or until completion of their follow-up in a sub-study, whichever is longer.

NCT Number	NCT06486454
Lead Sponsor	HistoSonics, Inc.
Conditions	Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver, Benign Liver Tumor
Enrollment	5,000 participants
Start Date	2024-10-14
Primary Completion	2026-11 (estimated)
Study Completion	2031-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-08