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RECRUITING
NCT06486454

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

Sponsor: HistoSonics, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2024-10-14

Completion Date

2031-11

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DEVICE

HistoSonics Edison System

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

Locations (27)

Providence St. Jude

Fullerton, California, United States

Mission Hospital

Mission Viejo, California, United States

Hoag

Newport Beach, California, United States

Sutter Bay Hospitals

San Francisco, California, United States

Providence Saint John's Health Center

Santa Monica, California, United States

AdventHealth Altamonte Springs

Altamonte Springs, Florida, United States

AdventHealth Celebration

Celebration, Florida, United States

Lee Health Cancer Institute

Fort Myers, Florida, United States

Baptist Health Miami Cardiac & Vascular Institute

Miami, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

RUSH University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Willis Knighton Health

Shreveport, Louisiana, United States

Henry Ford Health

Detroit, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Renown Regional Medical Center

Reno, Nevada, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

St. David's Medical Center

Austin, Texas, United States

Henrico Doctors' Hospital

Richmond, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States