Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
1 other identifier
observational
5,000
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedStudy Start
First participant enrolled
October 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2031
May 6, 2026
April 1, 2026
2 years
June 27, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histotripsy Technical Success
Histotripsy technical success, defined as completion of histotripsy on the target tumor(s) according to the histotripsy treatment plan, assessed by the treating physician on CT or MR imaging at ≤36 hours post-histotripsy treatment procedure. The histotripsy treatment plan will include identification of the intended complete or partial treatment of the tumor(s). The histotripsy treatment zone must provide target tumor coverage greater than or equal to the degree of treatment intended.
≤36 hours post-histotripsy treatment procedure
Study Arms (1)
HistoSonics Edison System
Interventions
Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors
Eligibility Criteria
Subjects who are 22 years of age or older with a diagnosis of: primary (e.g., HCC, cholangiocarcinoma, angiosarcoma) or metastatic (from other primary cancers) liver cancer, or benign liver tumors (e.g., adenoma).
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Providence St. Jude
Fullerton, California, 92835, United States
Mission Hospital
Mission Viejo, California, 92691, United States
Hoag
Newport Beach, California, 92663, United States
Sutter Bay Hospitals
San Francisco, California, 94107, United States
Providence Saint John's Health Center
Santa Monica, California, 90404, United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701, United States
AdventHealth Celebration
Celebration, Florida, 34747, United States
Lee Health Cancer Institute
Fort Myers, Florida, 33905, United States
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
RUSH University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Willis Knighton Health
Shreveport, Louisiana, 71103, United States
Mass General Brigham
Boston, Massachusetts, 02115, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. David's Medical Center
Austin, Texas, 78705, United States
Henrico Doctors' Hospital
Richmond, Virginia, 23229, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 3, 2024
Study Start
October 14, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2031
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share