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 2026-06-03
5000
Participants Needed
30
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world information on the use of the HistoSonics Edison System, a device used for histotripsy treatment of liver tumors. This observational study aims to understand how different patient and procedural characteristics affect the success of histotripsy at 36 hours after treatment. The study also includes sub-studies focusing on specific patient groups or clinical questions with stricter criteria and follow-up schedules. Participants will receive histotripsy treatment of their liver tumors using the HistoSonics Edison System. After treatment, imaging will be performed within 36 hours to assess the success of the procedure. Participants will then be followed according to each site's standard clinical care, with regular monitoring for adverse events. Sub-study participants may have additional assessments and follow-up as defined by those protocols. During the study, information will be collected before, during, and after the histotripsy procedure. Participants will have imaging assessments and clinical follow-up for up to 5 years or until they complete follow-up in any sub-study. The main outcome measured is the technical success of the histotripsy treatment at 36 hours post-procedure. Safety and treatment effects will be monitored throughout the follow-up period.
CONDITIONS
Brief 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 or older
- Subject has signed an approved informed consent form and agrees to comply with study procedures and follow-up
- Subject's liver tumor(s) can be partially or completely treated with histotripsy
You will not qualify if you...
- Subject is pregnant, planning to become pregnant, or breastfeeding during the study period
- Subject is enrolled in an interventional HistoSonics-sponsored trial
- Subject has a concurrent condition that could jeopardize safety or compliance with the study protocol according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo histotripsy treatment with the HistoSonics Edison System for full or partial destruction of liver tumors.
1 visit for treatment
Duration - ≤36 hours post-treatment
Participants receive imaging within 36 hours after histotripsy treatment to assess treatment success.
1 imaging visit (in-person)
Duration - Up to 5 years
Participants are followed with standard clinical follow-up including regular review of adverse event data for up to 5 years or until completion of follow-up in a sub-study.
Regular follow-up visits as determined by treating physician
Trial Site Locations
Total: 30 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
Novant Health
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
23
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
24
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
25
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
26
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
27
St. David's Medical Center
Austin, Texas, United States, 78705
Actively Recruiting
28
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23229
Actively Recruiting
29
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
30
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
M
Michelle Biedenfeld
C
Christine Frederiksen
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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