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

Recruitingn/aAges 22 Years - anyAllHistoSonics, Inc.
NCT06486454 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
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
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What it tests

  • HistoSonics Edison System
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Where

33 sites
Providence St. Jude
Fullerton, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Mission Hospital
Mission Viejo, United States
Hoag
Newport Beach, United States
Sutter Bay Hospitals
San Francisco, United States
Providence Saint John's Health Center
Santa Monica, United States
AdventHealth Altamonte Springs
Altamonte Springs, United States
AdventHealth Celebration
Celebration, United States

…and 25 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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