Recruiting

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

Sponsor:

HistoSonics, Inc.

Code:

NCT06486454

Conditions

Liver Neoplasms

Primary Liver Cancer

Secondary Liver Cancer

Tumor Liver

Benign Liver Tumor

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

HistoSonics Edison System

Study Details

Brief 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.

Conditions

Liver Neoplasms

Primary Liver Cancer

Secondary Liver Cancer

Tumor Liver

Benign Liver Tumor

Study ID

NCT06486454

Start date

Oct 14, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

HistoSonics Edison System

Interventions

HistoSonics Edison System

Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors

Primary outcome measure

Histotripsy Technical Success [ Time Frame: ≤36 hours post-histotripsy treatment procedure ]

Central Contacts and Locations

Central contacts

Michelle Biedenfeld

605-354-1448 Michelle.Biedenfeld@histosonics.com

Christine Frederiksen

307-262-7118 christine.frederiksen@histosonics.com

Locations

Providence St. Jude

Recruiting

Fullerton, California, United States, 92835

Contacts

Veronica Aguilar

veronica.aguilar2@providence.org

Principal Investigator:

David Park, MD

Mission Hospital

Recruiting

Mission Viejo, California, United States, 92691

Contacts

Kinnedy Houston

kinnedy.houston@providence.org

Principal Investigator:

Kevin Burns, MD

Hoag

Recruiting

Newport Beach, California, United States, 92663

Contacts

Vicki Tan

vicki.tan@hoag.org

Principal Investigator:

Trushar Patel, MD

Sutter Bay Hospitals

Recruiting

San Francisco, California, United States, 94107

Contacts

Maya Eshel

415-600-0865 maya.eshel@sutterhealth.org

Principal Investigator:

Casey Ward, MD

Providence Saint John's Health Center

Recruiting

Santa Monica, California, United States, 90404

Contacts

Joey Dumadag

joey.dumadag@providence.org

Principal Investigator:

Paul Shin, MD

AdventHealth Celebration

Recruiting

Celebration, Florida, United States, 34747

Contacts

Andrea Chiriboga

Andrea.Chiriboga@adventhealth.com

Principal Investigator:

Andrew Guzowski, MD

Lee Health Cancer Institute

Recruiting

Fort Myers, Florida, United States, 33905

Contacts

Lee Health Research Department

RCCR@leehealth.org

Principal Investigator:

Mark Bloomston, MD

Northeast Georgia Medical Center

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Trena Davis

trena.davis@nghs.com

Principal Investigator:

Terence Jackson, MD

RUSH University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Karl Villanueva

Karl_Villanueva@rush.edu

Principal Investigator:

Jordan Tasse, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Tiana Jackson

tiana.jackson@bsd.uchicago.edu

Principal Investigator:

Abdul Khan, MD

Willis Knighton Health

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Briana Barrow

bbarrow@wkhs.com

Principal Investigator:

Gazi Zibari, MD

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Maggie Connolly

mconnolly27@mgh.harvard.edu

Principal Investigator:

Jiping Wang, MD, PhD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Niya Boby

313-916-4596 nboby1@hfhs.org

Principal Investigator:

Atsushi Yoshida, MD

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Jensen Jantz

research@umhwest.org

Principal Investigator:

Michael Koets, MD

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Katie Buckley

Katie.Buckley@renown.org

Principal Investigator:

Nick Manguso, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Stanley Cobos

stanley.cobos@nyulangone.org

Principal Investigator:

Brock Hewitt, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Ihor Hursh

ih2432@cumc.columbia.edu

Principal Investigator:

Stephen Reis, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Nishtha Singh

nis4025@med.cornell.edu

Principal Investigator:

Juan Rocca, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Cristina Jimenez-Soto

cristina_jimenezsoto@urmc.rochester.edu

Principal Investigator:

Koji Tomiyama, MD

Novant Health

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Alison Rankin

alison.rankin@novanthealth.org

Principal Investigator:

David Sindram, MD

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Katie Pugh

937-438-7815 kmpugh@premierhealth.com

Principal Investigator:

James Ouellette, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Erlind Allkushi

ALLKUSE2@ccf.org

Principal Investigator:

Jaekeun Kim, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Gage Spears

614-293-8315 gage.spears@osumc.edu

Principal Investigator:

Mina Makary, MD

Lehigh Valley Hospital

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Jessie Panick

jessie.panick@jefferson.edu

Principal Investigator:

Errin Hoffman, MD

St. David's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Krishna Saini

krishna.saini@stdavids.com

Principal Investigator:

Shaun McKenzie, MD

Henrico Doctors' Hospital

Recruiting

Richmond, Virginia, United States, 23229

Contacts

Megan Edwards

423.779.2720 Megan.Edwards@hcahealthcare.com

Principal Investigator:

Laurie Cuttino, MD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Caitlin Normoyle

cnormoyle@uwhealth.org

Principal Investigator:

John Swietlik, MD

More Information

Sponsor

HistoSonics, Inc.

Last update posted

Jul 8, 2026

Last verified

Jun, 2026

Keywords

histotripsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by HistoSonics, Inc. on 2026-07-08.