Status:
RECRUITING
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Lead Sponsor:
HistoSonics, Inc.
Conditions:
Liver Neoplasms
Primary Liver Cancer
Eligibility:
All Genders
22+ years
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 charac...
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-histotr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
- Subject is enrolled in an interventional HistoSonics-sponsored trial
- Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
Key Trial Info
Start Date :
October 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06486454
Start Date
October 14 2024
End Date
November 1 2031
Last Update
November 14 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence St. Jude
Fullerton, California, United States, 92835
2
Mission Hospital
Mission Viejo, California, United States, 92691
3
Hoag
Newport Beach, California, United States, 92663
4
Providence Saint John's Health Center
Santa Monica, California, United States, 90404