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Sound waves zapping liver tumors: new study tracks Real-World success

NCT ID NCT06486454

Disease control Sponsor: HistoSonics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study is collecting information on how well the HistoSonics Edison System, which uses sound waves (histotripsy) to destroy liver tumors, works in everyday medical practice. Up to 5,000 adults with liver tumors will be followed for up to 5 years after treatment. The main goal is to see how patient and procedure factors affect whether the tumor is successfully treated within 36 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Histotripsy (sound wave therapy) via the HistoSonics Edison System
What this could lead to
If successful, this could show that histotripsy is a safe and effective non-invasive option for treating liver tumors, potentially reducing the need for surgery or radiation.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Success depends on tumor type and patient factors, and long-term outcomes are still being tracked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2039

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

hepatobiliary benign neoplasm hepatocellular carcinoma liver and intrahepatic bile duct neoplasm liver cancer Liver Neoplasms secondary malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign liver tumor Liver neoplasms Primary liver cancer Secondary liver cancer Tumor liver

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    30 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Altamonte Springs

    WITHDRAWN

    Altamonte Springs, Florida, 32701, United States

  • AdventHealth Celebration

    RECRUITING

    Celebration, Florida, 34747, United States

  • Baptist Health Miami Cardiac & Vascular Institute

    WITHDRAWN

    Miami, Florida, 33176, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Henrico Doctors' Hospital

    RECRUITING

    Richmond, Virginia, 23229, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hoag

    RECRUITING

    Newport Beach, California, 92663, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Lee Health Cancer Institute

    RECRUITING

    Fort Myers, Florida, 33905, United States

  • Lehigh Valley Hospital

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Mass General Brigham

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Miami Valley Hospital South

    RECRUITING

    Centerville, Ohio, 45459, United States

  • Mission Hospital

    RECRUITING

    Mission Viejo, California, 92691, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Northeast Georgia Medical Center

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Novant Health

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Providence Saint John's Health Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • Providence St. Jude

    RECRUITING

    Fullerton, California, 92835, United States

  • RUSH University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • St. David's Medical Center

    RECRUITING

    Austin, Texas, 78705, United States

  • Sutter Bay Hospitals

    RECRUITING

    San Francisco, California, 94107, United States

  • Swedish Medical Center

    TERMINATED

    Seattle, Washington, 98122, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Michigan Health - West

    RECRUITING

    Wyoming, Michigan, 49519, United States

    Contact Email: •••••@•••••

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

  • Willis Knighton Health

    RECRUITING

    Shreveport, Louisiana, 71103, United States

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