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

Launched by HISTOSONICS, INC. · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial, called the BOOMBOX: Master Study, is looking at a new treatment method for liver tumors using a device called the HistoSonics Edison System. The main goal is to gather information on how well this treatment works for different patients and their specific types of liver tumors, including both cancerous and non-cancerous growths. Researchers want to see how various factors, like a patient’s age or health condition, affect the treatment's success within 36 hours after it’s done. There are also smaller studies within this trial that will focus on particular groups of patients or specific questions to get more detailed information.

To participate, you need to be at least 22 years old, have a liver tumor that can be treated with this new method, and agree to follow the study's guidelines. Unfortunately, pregnant or nursing women and those involved in other HistoSonics studies cannot join. If you do participate, you will receive the histotripsy treatment and will be monitored for up to five years afterward to see how you respond to the treatment and to ensure your safety. The study aims to provide valuable insights that could improve future liver tumor treatments.

Gender

ALL

Eligibility criteria

• 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