Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Eligible age
22+ yrs
Accepts
All genders
Locations
16 states
Healthy volunteers
No
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About this 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.
Sponsor: HistoSonics, Inc.
You may qualify if…
- ✓ 1. Subject is ≥22 years of age
- ✓ 2. 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
- ✓ 3. Subject's liver tumor(s) can be partially or completely treated with histotripsy
You may not qualify if…
- ✕ 1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
- ✕ 2. Subject is enrolled in an interventional HistoSonics-sponsored trial
- ✕ 3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
Where it's recruiting
Fullerton · Mission Viejo · Newport Beach · San Francisco …
Altamonte Springs · Celebration · Fort Myers · Miami
Gainesville
Chicago
Shreveport
Boston
Detroit · Wyoming
Reno
New York · Rochester
Winston-Salem
Centerville · Cleveland · Columbus
Allentown
Source: ClinicalTrials.gov · NCT06486454 · last updated 2026-06-03