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

Recruiting now

Conditions studied: Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver, Benign Liver Tumor

In brief

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.

Key facts

Study ID

NCT06486454

Run by

HistoSonics, Inc.

People needed

5000

Starts

2024-10-14

Expected to finish

2031-11-01

Last updated by the study team

2026-07-08

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥22 years of age
• Subject has signed the Ethics Committee (EC), or Institutional Review Board (IRB) approved study Informed Consent Form (ICF) prior to any study related tests/procedures and is willing to comply with study procedures and required follow-up assessments
• Subject's liver tumor(s) can be partially or completely treated with histotripsy

You may not qualify if…

• 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

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Mission Hospital — Mission Viejo, California, United States (enrolling)
• Hoag — Newport Beach, California, United States (enrolling)
• Sutter Bay Hospitals — San Francisco, California, United States (enrolling)
• Providence Saint John's Health Center — Santa Monica, California, United States (enrolling)
• St. David's Medical Center — Austin, Texas, United States (enrolling)
• Henrico Doctors' Hospital — Richmond, Virginia, United States (enrolling)
• Providence St. Jude — Fullerton, California, United States (enrolling)
• AdventHealth Celebration — Celebration, Florida, United States (enrolling)
• Lee Health Cancer Institute — Fort Myers, Florida, United States (enrolling)
• Northeast Georgia Medical Center — Gainesville, Georgia, United States (enrolling)
• RUSH University Medical Center — Chicago, Illinois, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Willis Knighton Health — Shreveport, Louisiana, United States (enrolling)
• Mass General Brigham — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• University of Michigan Health - West — Wyoming, Michigan, United States (enrolling)
• Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• Novant Health — Winston-Salem, North Carolina, United States (enrolling)
• Miami Valley Hospital South — Centerville, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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