Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) (NCT06486454)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (4 items).
Location: Providence St. Jude — Fullerton, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
- Subject is enrolled in an interventional HistoSonics-sponsored trial
- Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (30 Sites)
- Providence St. Jude — Fullerton, California
- Mission Hospital — Mission Viejo, California
- Hoag — Newport Beach, California
- Sutter Bay Hospitals — San Francisco, California
- Providence Saint John's Health Center — Santa Monica, California
- AdventHealth Altamonte Springs — Altamonte Springs, Florida
- AdventHealth Celebration — Celebration, Florida
- Lee Health Cancer Institute — Fort Myers, Florida
- Baptist Health Miami Cardiac & Vascular Institute — Miami, Florida
- Northeast Georgia Medical Center — Gainesville, Georgia
- RUSH University Medical Center — Chicago, Illinois
- University of Chicago — Chicago, Illinois
- Willis Knighton Health — Shreveport, Louisiana
- Mass General Brigham — Boston, Massachusetts
- Henry Ford Health — Detroit, Michigan
- University of Michigan Health - West — Wyoming, Michigan
- Renown Regional Medical Center — Reno, Nevada
- NYU Langone Health — New York, New York
- Columbia University Irving Medical Center — New York, New York
- Weill Cornell Medicine — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Novant Health — Winston-Salem, North Carolina
- Miami Valley Hospital South — Centerville, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.