Observational Study of the Edison System for Liver Tumor Treatment
Collects information on patients with liver tumors treated with the Edison histotripsy device.
Plain-language title generated from the registry record
Registry title: Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Key facts
- Where
- Allentown, Altamonte Springs, Austin, Baltimore, Boston, Celebration, Centerville, Chicago, Cleveland, Columbus, Detroit, Fort Myers, Fullerton, Gainesville, Los Angeles, Madison, Manhasset, Miami, Mission Viejo, Mobile, New York, Newport Beach, Reno, Richmond, Rochester, San Francisco, Santa Monica, Seattle, Shreveport, Winston-Salem, and Wyoming, United StatesSee the 35 sites
Where in United States
- LeHigh Valley HospitalAllentown, United StatesTaking people
- AdventHealth Altamonte SpringsAltamonte Springs, United StatesNo longer taking part
- St. David's Medical CenterAustin, United StatesTaking people
- Johns Hopkins HospitalBaltimore, United StatesTaking people
- Mass General BrighamBoston, United StatesTaking people
- AdventHealth CelebrationCelebration, United StatesTaking people
- Miami Valley Hospital SouthCenterville, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Henry Ford HealthDetroit, United StatesTaking people
- Lee Health Cancer InstituteFort Myers, United StatesTaking people
- Providence St. JudeFullerton, United StatesTaking people
- Northeast Georgia Medical CenterGainesville, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- University of WisconsinMadison, United StatesTaking people
- Northwell HealthManhasset, United StatesTaking people
- Baptist Health Miami Cardiac & Vascular InstituteMiami, United StatesNo longer taking part
- Mission HospitalMission Viejo, United StatesTaking people
- University of South AlabamaMobile, United StatesTaking people
- Columbia University Irving Medical CenterNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- Weill Cornell MedicineNew York, United StatesTaking people
- HOAGNewport Beach, United StatesTaking people
- Renown Regional Medical CenterReno, United StatesTaking people
- Henrico Doctors' HospitalRichmond, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- Sutter Bay HospitalsSan Francisco, United StatesTaking people
- Providence Saint John's Health CenterSanta Monica, United StatesTaking people
- Swedish Medical CenterSeattle, United StatesNo longer taking part
- Willis Knighton HealthShreveport, United StatesTaking people
- Novant HealthWinston-Salem, United StatesTaking people
- University of Michigan Health - WestWyoming, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HistoSonics, Inc.
- Trial code
- NCT06486454
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master 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.
Inclusion: 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.
Exclusion: Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol; Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period; Subject is enrolled in an interventional HistoSonics-sponsored trial.