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Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Sponsor: HistoSonics, Inc.
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.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2024-10-14
Completion Date
2031-11
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
HistoSonics Edison System
Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors
Locations (27)
Providence St. Jude
Fullerton, California, United States
Mission Hospital
Mission Viejo, California, United States
Hoag
Newport Beach, California, United States
Sutter Bay Hospitals
San Francisco, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, United States
AdventHealth Celebration
Celebration, Florida, United States
Lee Health Cancer Institute
Fort Myers, Florida, United States
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
RUSH University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Willis Knighton Health
Shreveport, Louisiana, United States
Henry Ford Health
Detroit, Michigan, United States
University of Michigan Health - West
Wyoming, Michigan, United States
Renown Regional Medical Center
Reno, Nevada, United States
NYU Langone Health
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. David's Medical Center
Austin, Texas, United States
Henrico Doctors' Hospital
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States