Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (4573% higher). The listed sponsor is HistoSonics, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
-
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors
RECRUITING · Phase 2
-
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
RECRUITING · Phase 1
-
Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
RECRUITING · Phase 2
-
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy
ACTIVE NOT RECRUITING · NA
-
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor
ACTIVE NOT RECRUITING · Phase 1
-
SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization
COMPLETED · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.