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

RecruitingObservational study

Who can join

Ages 22 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

1. Subject is ≥22 years of age
2. 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
3. Subject's liver tumor(s) can be partially or completely treated with histotripsy

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
2. Subject is enrolled in an interventional HistoSonics-sponsored trial
3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

About the 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.

What is being tested

HistoSonics Edison System (device)

Sponsor: HistoSonics, Inc. · Participants: 5,000 · Started: Oct 14, 2024

Contact the study team

Michelle Biedenfeld · Phone: 605-354-1448
Christine Frederiksen · Phone: 307-262-7118

Official record on ClinicalTrials.gov — NCT06486454

Locations in the U.S.

California	Providence St. Jude, Fullerton Cedars-Sinai Medical Center, Los Angeles Mission Hospital, Mission Viejo Hoag, Newport Beach Sutter Bay Hospitals, San Francisco Providence Saint John's Health Center, Santa Monica
Florida	AdventHealth Celebration, Celebration Lee Health Cancer Institute, Fort Myers
Georgia	Northeast Georgia Medical Center, Gainesville
Illinois	RUSH University Medical Center, Chicago University of Chicago, Chicago
Louisiana	Willis Knighton Health, Shreveport
Maryland	Johns Hopkins Hospital, Baltimore
Massachusetts	Mass General Brigham, Boston
Michigan	Henry Ford Health, Detroit University of Michigan Health - West, Wyoming
Nevada	Renown Regional Medical Center, Reno
New York	Columbia University Irving Medical Center, New York Memorial Sloan Kettering Cancer Center, New York NYU Langone Health, New York Weill Cornell Medicine, New York University of Rochester Medical Center, Rochester
North Carolina	Novant Health, Winston-Salem
Ohio	Miami Valley Hospital South, Centerville Cleveland Clinic Foundation, Cleveland The Ohio State University, Columbus
Pennsylvania	Lehigh Valley Hospital, Allentown
Texas	St. David's Medical Center, Austin
Virginia	Henrico Doctors' Hospital, Richmond
Wisconsin	University of Wisconsin, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.