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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Subject is ≥22 years of age

• 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

• Subject's liver tumor(s) can be partially or completely treated with histotripsy

Locations
United States
California
Providence St. Jude
RECRUITING
Fullerton
Mission Hospital
RECRUITING
Mission Viejo
Florida
AdventHealth Altamonte Springs
RECRUITING
Altamonte Springs
AdventHealth Celebration
RECRUITING
Celebration
Lee Health Cancer Institute
RECRUITING
Fort Myers
Baptist Health Miami Cardiac & Vascular Institute
RECRUITING
Miami
Georgia
Northeast Georgia Medical Center
RECRUITING
Gainesville
Illinois
RUSH University Medical Center
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Michigan
University of Michigan Health - West
RECRUITING
Wyoming
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
Columbia University Irving Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
Lehigh Valley Hospital
RECRUITING
Allentown
Texas
St. David's Medical Center
RECRUITING
Austin
Washington
Swedish Medical Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Christine Graham
christine.graham@histosonics.com
612-200-1293
Backup
Christine Frederiksen
christine.frederiksen@histosonics.com
307-262-7118
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2031-11
Participants
Target number of participants: 5000
Treatments
HistoSonics Edison System
Related Therapeutic Areas
Sponsors
Leads: HistoSonics, Inc.

This content was sourced from clinicaltrials.gov