RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-14
Study Completion:2031-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06486454

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is ≥22 years of age
  2. 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. 3. Subject's liver tumor(s) can be partially or completely treated with histotripsy
  1. 1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
  2. 2. Subject is enrolled in an interventional HistoSonics-sponsored trial
  3. 3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

Contacts and Locations

Study Contact

Christine Graham
CONTACT
612-200-1293
christine.graham@histosonics.com
Christine Frederiksen
CONTACT
307-262-7118
christine.frederiksen@histosonics.com

Study Locations (Sites)

Mission Hospital
Mission Viejo, California, 92691
United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-10-14
Study Completion Date2031-11

Study Record Updates

Study Start Date2024-10-14
Study Completion Date2031-11

Terms related to this study

Keywords Provided by Researchers

  • histotripsy

Additional Relevant MeSH Terms

  • Liver Neoplasms
  • Primary Liver Cancer
  • Secondary Liver Cancer
  • Tumor Liver
  • Benign Liver Tumor