Liver NeoplasmsNCT06486454
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
An observational study of Liver Neoplasms and Primary Liver Cancer, run by HistoSonics, Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer
- What is being tested?
- HistoSonics Edison System
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 35 sitesUnited States
- Study dates
- 14 Oct 2024to Nov 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are 22 years of age or older with a diagnosis of: primary (e.g., HCC, cholangiocarcinoma, angiosarcoma) or metastatic (from other primary cancers) liver cancer, or benign liver tumors (e.g., adenoma).
Who may be able to join
- Subject is ≥22 years of age
- 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
- Subject's liver tumor(s) can be partially or completely treated with histotripsy
Who cannot join
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
- Subject is enrolled in an interventional HistoSonics-sponsored trial
- Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
United States35 sites, 32 recruiting
- Recruiting
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Jessie Panick, jessie.panick@jefferson.edu
Errin Hoffman, MD
- Withdrawn
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
- Recruiting
St. David's Medical Center
Austin, Texas, 78705
Krishna Saini, krishna.saini@stdavids.com
Shaun McKenzie, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Mehreen Nabi, mnabi1@jhmi.edu
Cristos Georgiades, MD, PhD
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02115
Maggie Connolly, mconnolly27@mgh.harvard.edu
Jiping Wang, MD, PhD
- Recruiting
AdventHealth Celebration
Celebration, Florida, 34747
Andrea Chiriboga, Andrea.Chiriboga@adventhealth.com
Andrew Guzowski, MD
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Katie Pugh, 937-438-7815, kmpugh@premierhealth.com
James Ouellette, MD
- Recruiting
RUSH University Medical Center
Chicago, Illinois, 60612
Karl Villanueva, Karl_Villanueva@rush.edu
Jordan Tasse, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Tiana Jackson, tiana.jackson@bsd.uchicago.edu
Abdul Khan, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Erlind Allkushi, ALLKUSE2@ccf.org
Jaekeun Kim, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Gage Spears, 614-293-8315, gage.spears@osumc.edu
Mina Makary, MD
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Niya Boby, 313-916-4596, nboby1@hfhs.org
Atsushi Yoshida, MD
- Recruiting
Lee Health Cancer Institute
Fort Myers, Florida, 33905
Lee Health Research Department, RCCR@leehealth.org
Mark Bloomston, MD
- Recruiting
Providence St. Jude
Fullerton, California, 92835
Veronica Aguilar, veronica.aguilar2@providence.org
David Park, MD
- Recruiting
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Trena Davis, trena.davis@nghs.com
Terence Jackson, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ali Sanford, Alison.Sanford@cshs.org
Nicholas Nissen, MD
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Caitlin Normoyle, cnormoyle@uwhealth.org
John Swietlik, MD
- Recruiting
Northwell Health
Manhasset, New York, 11030
Fellanza Cacaj, MD, Fcacaj1@northwell.edu
Laurence Lau, MD
- Withdrawn
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida, 33176
- Recruiting
Mission Hospital
Mission Viejo, California, 92691
Kinnedy Houston, kinnedy.houston@providence.org
Kevin Burns, MD
- Recruiting
University of South Alabama
Mobile, Alabama, 36688
Sara Witherington, sara.witherington@health.southalabama.edu
Natalie Bath, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Stanley Cobos, stanley.cobos@nyulangone.org
Brock Hewitt, MD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Anna Pesheva, ap5068@cumc.columbia.edu
Stephen Reis, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Henry Kunin, kuninh@mskcc.org
Vlasios Sotirchos, MD
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Nishtha Singh, nis4025@med.cornell.edu
Juan Rocca, MD
- Recruiting
Hoag
Newport Beach, California, 92663
Vicki Tan, vicki.tan@hoag.org
Trushar Patel, MD
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Katie Buckley, Katie.Buckley@renown.org
Nick Manguso, MD
- Recruiting
Henrico Doctors' Hospital
Richmond, Virginia, 23229
Megan Edwards, 423.779.2720, Megan.Edwards@hcahealthcare.com
Laurie Cuttino, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Cristina Jimenez-Soto, cristina_jimenezsoto@urmc.rochester.edu
Koji Tomiyama, MD
- Recruiting
Sutter Bay Hospitals
San Francisco, California, 94107
Maya Eshel, 415-600-0865, maya.eshel@sutterhealth.org
Casey Ward, MD
- Recruiting
Providence Saint John's Health Center
Santa Monica, California, 90404
Joey Dumadag, joey.dumadag@providence.org
Paul Shin, MD
- Terminated
Swedish Medical Center
Seattle, Washington, 98122
- Recruiting
Willis Knighton Health
Shreveport, Louisiana, 71103
Briana Barrow, bbarrow@wkhs.com
Gazi Zibari, MD
- Recruiting
Novant Health
Winston-Salem, North Carolina, 27103
Alison Rankin, alison.rankin@novanthealth.org
David Sindram, MD
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Jensen Jantz, research@umhwest.org
Michael Koets, MD
About this 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 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.
Read the detailed description
BOOMBOX: Master Study is an observational, single arm, non-randomized, prospective master study. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-histotripsy treatment procedure to determine histotripsy success. Subjects will then be followed per standard clinical follow-up as determined at each site with regular review of adverse event data for up to 5 years or until completion of their follow-up in a sub-study, whichever is longer.
As an observational study, the master protocol does not direct the use of the HistoSonics Edison System towards any specific clinical intent or any specific disease state. Rather, it will uniformly enroll patients and capture real-world standard-of-care data on the usage of the HistoSonics Edison System as implemented by the treating physician on all subjects treated with histotripsy that meet the study criteria and agree to participate in the study. Sub-studies to the master protocol will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any subject enrolled in the master study who also qualifies for a sub-study may enroll in the sub-study in parallel to the master study.
- Conditions
- Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver, Benign Liver Tumor
- Being tested
- HistoSonics Edison System
- Keywords
- histotripsy
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoSonics Edison SystemDevice
Also called Histotripsy
Histotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors
| Study group | Role | What they receive |
|---|---|---|
| HistoSonics Edison System | Not described Receives: Device: HistoSonics Edison System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histotripsy Technical Success
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.
Measured: ≤36 hours post-histotripsy treatment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Oct 2024
- Primary completionNov 2034 (estimated)
- Study completionNov 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HistoSonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486454
- Sponsor's protocol ID
- CSP3828
- Status last verified
- Nov 2026
- First submitted
- 27 Jun 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
- ClinicalTrials.gov ID
- NCT06486454
- Acronym / sponsor ID
- CSP3828
- Conditions
- Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver, Benign Liver Tumor
- Keywords
- histotripsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Nov 2034 (estimated)
- Study completion
- Nov 2039 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BOOMBOX: Master Study is an observational, single arm, non-randomized, prospective master study. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-histotripsy treatment procedure to determine histotripsy success. Subjects will then be followed per standard clinical follow-up as determined at each site with regular review of adverse event data for up to 5 years or until completion of their follow-up in a sub-study, whichever is longer.
As an observational study, the master protocol does not direct the use of the HistoSonics Edison System towards any specific clinical intent or any specific disease state. Rather, it will uniformly enroll patients and capture real-world standard-of-care data on the usage of the HistoSonics Edison System as implemented by the treating physician on all subjects treated with histotripsy that meet the study criteria and agree to participate in the study. Sub-studies to the master protocol will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any subject enrolled in the master study who also qualifies for a sub-study may enroll in the sub-study in parallel to the master study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HistoSonics Edison System | – | Device: HistoSonics Edison System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are 22 years of age or older with a diagnosis of: primary (e.g., HCC, cholangiocarcinoma, angiosarcoma) or metastatic (from other primary cancers) liver cancer, or benign liver tumors (e.g., adenoma).
Key inclusion criteria (3 listed)
- Subject is ≥22 years of age
- 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
- Subject's liver tumor(s) can be partially or completely treated with histotripsy
Key exclusion criteria (3 listed)
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period
- Subject is enrolled in an interventional HistoSonics-sponsored trial
- Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistoSonics Edison SystemAlso: HistotripsyHistotripsy with the HistoSonics Edison System for the full or partial destruction of liver tumors | Device | HistoSonics Edison System |
Primary outcome
Histotripsy Technical Success
Time frame: ≤36 hours post-histotripsy treatment procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Primary Liver Cancer, run by HistoSonics, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Biedenfeld (605-354-1448, Michelle.Biedenfeld@histosonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histotripsy Technical Success (time frame: ≤36 hours post-histotripsy treatment procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.