Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
NCT06486454 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- DEVICE HistoSonics Edison System
Study Locations (20)
California
- Providence St. Jude — Fullerton
- Mission Hospital — Mission Viejo
- Hoag — Newport Beach
- Providence Saint John's Health Center — Santa Monica
Florida
- AdventHealth Altamonte Springs — Altamonte Springs
- AdventHealth Celebration — Celebration
- Lee Health Cancer Institute — Fort Myers
- Baptist Health Miami Cardiac & Vascular Institute — Miami
New York
- NYU Langone Health — New York
- Columbia University Irving Medical Center — New York
- Weill Cornell Medicine — New York
- University of Rochester Medical Center — Rochester
Illinois
- RUSH University Medical Center — Chicago
- University of Chicago — Chicago
Michigan
- Henry Ford Health — Detroit
- University of Michigan Health - West — Wyoming
Georgia
- Northeast Georgia Medical Center — Gainesville
Louisiana
- Willis Knighton Health — Shreveport
Nevada
- Renown Regional Medical Center — Reno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2031-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06486454
The ClinicalTrials.gov registry entry for NCT06486454 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HistoSonics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Liver Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which HistoSonics Edison System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06486454 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06486454 about?
NCT06486454 is a clinical study titled "Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)". 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...
What is the current status of trial NCT06486454?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2024-10-14. Estimated completion is 2031-11.
What conditions does trial NCT06486454 study?
This clinical trial studies the following conditions: Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Benign Liver Tumor, Tumor Liver. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06486454?
The interventions under investigation include: HistoSonics Edison System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06486454?
This trial is sponsored by HistoSonics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06486454 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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