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Evaluation of the HistoSonics Edison System for treating liver tumors

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

HistoSonics, Inc. · NCT06486454

This study is testing how well the HistoSonics Edison System works for treating liver tumors and how different factors affect the treatment's success in real patients.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages22 Years and up
SexAll
SponsorHistoSonics, Inc. (industry)
Locations29 sites (Fullerton, California and 28 other locations)
Trial IDNCT06486454 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the use of the HistoSonics Edison System for treating various liver tumors. It will assess how patient and procedural characteristics influence the success of histotripsy treatment within 36 hours post-procedure. Participants will be monitored for up to five years, with the possibility of enrolling in sub-studies that focus on specific populations or clinical questions. The study will collect comprehensive data before, during, and after the treatment to evaluate outcomes and adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with liver tumors that can be treated with histotripsy.

Not a fit: Patients who are pregnant, nursing, or have conditions that may compromise their safety or compliance with the study will not benefit.

Why it matters

Potential benefit: If successful, this study could enhance treatment options and outcomes for patients with liver tumors.

How similar studies have performed: While this approach is observational, similar studies using innovative treatment methods have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Fullerton, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver, Benign Liver Tumor, histotripsy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.