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NCT06486454 · ClinicalTrials.gov registry record
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
A clinical trial of Liver Neoplasms and Primary Liver Cancer, sponsored by HistoSonics.
- Recruiting
- Registry status
- 5,000
- Enrollment target
- 20
- Study locations
NCT06486454: Recruiting study of Liver Neoplasms and Primary Liver Cancer, sponsored by HistoSonics.
NCT06486454 is a study of Liver Neoplasms and Primary Liver Cancer that is actively recruiting participants, run by HistoSonics. The registered enrollment target is 5,000 participants, above the 107-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (4573% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06486454, a study of Liver Neoplasms and Primary Liver Cancer, is actively recruiting participants, sponsored by HistoSonics.
- RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Histotripsy technical success, defined as completion of histotripsy on the target tumor(s) according to the histotripsy treatment plan, assessed by the treating physician on CT or MR imaging at ≤36 hours post-histotripsy treatment procedure. The histotripsy treatment plan will include identification of the intended complete or partial treatment of the tumor(s). The histotripsy treatment zone must provide target tumor coverage greater than or equal to the degree of treatment intended.
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 |
What NCT06486454 shows while recruiting
NCT06486454 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus, above the 107-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (4573% higher).
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.
NCT06486454 names 20 study sites across 9 states, led by California, Florida, New York.
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.
What interventions are being tested in trial NCT06486454?
The interventions under investigation include: HistoSonics Edison System (DEVICE).
Who is sponsoring clinical trial NCT06486454?
This trial is sponsored by HistoSonics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Liver Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06486454's enrollment target sits among peer trials
5,000 1st of 14 higher than 14 of 14 other Liver Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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