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

June 1, 2026 updated by: HistoSonics, Inc.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BOOMBOX: Master Study is an observational, single arm, non-randomized, prospective master study. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-histotripsy treatment procedure to determine histotripsy success. Subjects will then be followed per standard clinical follow-up as determined at each site with regular review of adverse event data for up to 5 years or until completion of their follow-up in a sub-study, whichever is longer.

As an observational study, the master protocol does not direct the use of the HistoSonics Edison System towards any specific clinical intent or any specific disease state. Rather, it will uniformly enroll patients and capture real-world standard-of-care data on the usage of the HistoSonics Edison System as implemented by the treating physician on all subjects treated with histotripsy that meet the study criteria and agree to participate in the study. Sub-studies to the master protocol will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any subject enrolled in the master study who also qualifies for a sub-study may enroll in the sub-study in parallel to the master study.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92835
      • Mission Viejo, California, United States, 92691
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag
        • Principal Investigator:
          • Trushar Patel, MD
        • Contact:
      • San Francisco, California, United States, 94107
        • Recruiting
        • Sutter Bay Hospitals
        • Contact:
        • Principal Investigator:
          • Casey Ward, MD
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence Saint John's Health Center
        • Contact:
        • Principal Investigator:
          • Paul Shin, MD
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Withdrawn
        • AdventHealth Altamonte Springs
      • Celebration, Florida, United States, 34747
      • Fort Myers, Florida, United States, 33905
        • Recruiting
        • Lee Health Cancer Institute
        • Principal Investigator:
          • Mark Bloomston, MD
        • Contact:
      • Miami, Florida, United States, 33176
        • Withdrawn
        • Baptist Health Miami Cardiac & Vascular Institute
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Medical Center
        • Contact:
        • Principal Investigator:
          • Terence Jackson, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Jordan Tasse, MD
        • Contact:
      • Chicago, Illinois, United States, 60637
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis Knighton Health
        • Contact:
        • Principal Investigator:
          • Gazi Zibari, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Mass General Brigham
        • Contact:
        • Principal Investigator:
          • Jiping Wang, MD, PhD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
        • Principal Investigator:
          • Atsushi Yoshida, MD
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Michael Koets, MD
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Nick Manguso, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Juan Rocca, MD
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Stephen Reis, MD
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Principal Investigator:
          • James Ouellette, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Jaekeun Kim, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Mina Makary, MD
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital
        • Contact:
        • Principal Investigator:
          • Errin Hoffman, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • St. David's Medical Center
        • Contact:
        • Principal Investigator:
          • Shaun McKenzie, MD
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • Henrico Doctors' Hospital
        • Contact:
        • Principal Investigator:
          • Laurie Cuttino, MD
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
        • Principal Investigator:
          • Evan Ong, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • John Swietlik, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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).

Description

Inclusion Criteria:

  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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HistoSonics Edison System
Device: HistoSonics Edison System
Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors
Other Names:
  • Histotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histotripsy Technical Success
Time Frame: ≤36 hours post-histotripsy treatment procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HistoSonics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP3828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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