Actively Recruiting
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Led by HistoSonics, Inc. · Updated on 2026-05-06
5000
Participants Needed
29
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Providence St. Jude
Fullerton, California, United States, 92835
Actively Recruiting
2
Mission Hospital
Mission Viejo, California, United States, 92691
Actively Recruiting
3
Hoag
Newport Beach, California, United States, 92663
Actively Recruiting
4
Sutter Bay Hospitals
San Francisco, California, United States, 94107
Actively Recruiting
5
Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
6
AdventHealth Altamonte Springs
Altamonte Springs, Florida, United States, 32701
Withdrawn
7
AdventHealth Celebration
Celebration, Florida, United States, 34747
Actively Recruiting
8
Lee Health Cancer Institute
Fort Myers, Florida, United States, 33905
Actively Recruiting
9
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida, United States, 33176
Withdrawn
10
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Actively Recruiting
11
RUSH University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
12
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
13
Willis Knighton Health
Shreveport, Louisiana, United States, 71103
Actively Recruiting
14
Mass General Brigham
Boston, Massachusetts, United States, 02115
Actively Recruiting
15
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
16
University of Michigan Health - West
Wyoming, Michigan, United States, 49519
Actively Recruiting
17
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
18
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
19
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
20
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
21
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
22
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
23
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
24
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
25
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
26
St. David's Medical Center
Austin, Texas, United States, 78705
Actively Recruiting
27
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23229
Actively Recruiting
28
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
29
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
M
Michelle Biedenfeld
CONTACT
C
Christine Frederiksen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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