Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)

ClinicalTrials.gov ID: NCT06486454

Public ClinicalTrials.gov record NCT06486454. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06486454
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: HistoSonics, Inc.; Industry
Enrollment: 5,000 participants

Conditions and interventions

Conditions

Interventions

HistoSonics Edison System Device

Device

Eligibility (public fields only)

Age range: 22 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 13, 2024
Primary completion: Oct 31, 2026
Completion: Oct 31, 2031
Last update posted: Jul 7, 2026

2024 – 2031

United States locations

U.S. sites: 30
U.S. states: 16
U.S. cities: 27

Facility	City	State	ZIP	Site status
Providence St. Jude	Fullerton	California	92835	Recruiting
Mission Hospital	Mission Viejo	California	92691	Recruiting
Hoag	Newport Beach	California	92663	Recruiting
Sutter Bay Hospitals	San Francisco	California	94107	Recruiting
Providence Saint John's Health Center	Santa Monica	California	90404	Recruiting
AdventHealth Altamonte Springs	Altamonte Springs	Florida	32701	Withdrawn
AdventHealth Celebration	Celebration	Florida	34747	Recruiting
Lee Health Cancer Institute	Fort Myers	Florida	33905	Recruiting
Baptist Health Miami Cardiac & Vascular Institute	Miami	Florida	33176	Withdrawn
Northeast Georgia Medical Center	Gainesville	Georgia	30501	Recruiting
RUSH University Medical Center	Chicago	Illinois	60612	Recruiting
University of Chicago	Chicago	Illinois	60637	Recruiting
Willis Knighton Health	Shreveport	Louisiana	71103	Recruiting
Mass General Brigham	Boston	Massachusetts	02115	Recruiting
Henry Ford Health	Detroit	Michigan	48202	Recruiting
University of Michigan Health - West	Wyoming	Michigan	49519	Recruiting
Renown Regional Medical Center	Reno	Nevada	89502	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
Columbia University Irving Medical Center	New York	New York	10032	Recruiting
Weill Cornell Medicine	New York	New York	10065	Recruiting
University of Rochester Medical Center	Rochester	New York	14642	Recruiting
Novant Health	Winston-Salem	North Carolina	27103	Recruiting
Miami Valley Hospital South	Centerville	Ohio	45459	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Recruiting
The Ohio State University	Columbus	Ohio	43210	Recruiting
Lehigh Valley Hospital	Allentown	Pennsylvania	18103	Recruiting
St. David's Medical Center	Austin	Texas	78705	Recruiting
Henrico Doctors' Hospital	Richmond	Virginia	23229	Recruiting
Swedish Medical Center	Seattle	Washington	98122	Terminated
University of Wisconsin	Madison	Wisconsin	53792	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06486454, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 7, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06486454 live on ClinicalTrials.gov.

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