The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy

NCT04572633 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: CSP1427
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 7

Brief Summary

This trial is a single arm, non-randomized prospective trial. The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver. The co-primary safety and efficacy endpoints must be met for the trial to be successful.

Conditions

Liver Neoplasms; Hepatocellular Carcinoma; Liver Metastases

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy: Technical Success

  Technical success, defined as the treatment volume/treatment dimensions being greater than or equal to the targeted tumor, and with complete tumor coverage, via computed tomography (CT) or magnetic resonance (MR) imaging. \[Core Laboratory Adjudicated\] Primary efficacy was assessed per tumor with a performance goal of greater than 70%. Primary efficacy was assessed after the first forty (40) consecutive evaluable subjects were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success.

  ≤36 hours post-index procedure

• Primary Safety: Procedure-Related Major Complications

  Number of index procedure related major complications, including device-related events defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher toxicities observed up to 30-days post index-procedure. \[Clinical Events Committee Adjudicated\] Primary safety was assessed per participant with a performance goal of less than 25%. Primary safety was assessed on all subjects enrolled, after the first forty (40) consecutive subjects evaluable for technical success were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success. Enrollment of 44 total subjects was required to assess forty (40) subjects evaluable for technical success.

  30 days post-index procedure

Secondary Outcomes (4)

• Technical Success

  ≤36 hours post-index procedure

• Procedure-Related Major Complications

  30 days post-index procedure

• Secondary Efficacy: Technique Efficacy

  30 days post-index procedure

• Secondary Safety: All Adverse Events

  30 days post-index procedure

Study Arms (1)

HistoSonics System

EXPERIMENTAL

Device: HistoSonics System

Interventions

HistoSonics System DEVICE

The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.

Also known as: Histotripsy

HistoSonics System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age
• Subject has signed the Ethics Committee (EC) or Institutional Review Board (IRB) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments
• Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
• Subject is able to undergo general anesthesia
• Subject has a Child-Pugh Score of A or B
• Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
• Subject meets the following functional criteria, ≤7 days prior to the index-procedure:
• Liver function: Alanine transaminase (ALT) and Aspartate transaminase (AST) \<2.5x upper limit of normal (ULN) and/or bilirubin \<2.5 ULN, and
• Renal function: serum creatinine \<2x ULN, and
• Hematologic function: neutrophil count \>1.0 x 10\^9/L and platelet \>50 x 10\^9/L
• Subject has an International Normalized Ratio (INR) score of \<2.0 , ≤7 days prior to the index procedure
• Subject has not responded to and/or has relapsed and/or is intolerant of other available therapies including locoregional therapies, chemotherapy, immunotherapy and targeted therapies
• The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
• Subject has an adequate acoustic window to visualize targeted tumor(s) using ultrasound imaging
• Subject has a maximum of three (3) tumors to be treated with histotripsy during the index procedure, regardless of how many tumors the subject has.

You may not qualify if:

• Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period
• Subject is enrolled in another investigational trial and/or is taking investigational medication and/or has been treated with an investigational device ≤30-days prior to planned index procedure date
• In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics System
• Subject has a serum creatinine \>2.0 mg/dL or estimated glomerular filtration rate (EGFR) \<30, unless on dialysis
• Subject has major surgical procedure or significant traumatic injury ≤2 weeks prior to the planned index procedure or not fully recovered (CTCAE grade 1 or better) from side effects/complications of such procedure or trauma
• Subject has not recovered to common terminology criteria for adverse events (CTCAE) grade 1 or better from any adverse effects (except alopecia, fatigue, nausea, vomiting and peripheral neuropathy) related to previous anti-cancer therapy
• Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
• Subject has coagulopathy that is uncorrectable
• Subject has a planned cancer treatment (e.g. resection, chemotherapy, etc.) after the planned index-procedure date and prior to completion of the 30-day follow-up visit
• Subject has previous treatment with bevacizumab that has not been discontinued \>40 days prior to the planned index-procedure date
• Subject has planned bevacizumab treatment prior to completion of the 30-day follow-up visit
• Subject has previous treatments with chemotherapy and/or radiotherapy that has not been discontinued ≥2 weeks prior to the planned index-procedure date and has not recovered (CTCAE grade 1 or better) from related toxicity (except alopecia and peripheral neuropathy)
• Subject has previous treatment with immunotherapies that has not been discontinued ≥4 weeks prior to the index-procedure and has not recovered from related toxicity (CTCAE grade 1 or better)
• Subject has a life expectancy less than six (\<6) months
• In the opinion of the Investigator, histotripsy is not a treatment option for the subject

Sponsors & Collaborators

• HistoSonics, Inc.: lead

Study Sites (7)

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109-5030, United States

Location

University Hospital - UW Health

Madison, Wisconsin, 53792-3252, United States

Location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Creixams X, White SB, Davis C, Ahmed O, Parikh ND, Planert M, Thormann M, Xu Z, Collins Z, Narayanan G, Torzilli G, Cho C, Littler P, Wah TM, Solbiati L, Ziemlewicz TJ. The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors. Radiology. 2024 Sep;312(3):e233051. doi: 10.1148/radiol.233051.

  PMID: 39225612 RESULT

• Ziemlewicz TJ, Critchfield JJ, Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Creixams X, Lubner M, Wah TM, Littler P, Davis CR, Narayanan G, White SB, Ahmed O, Collins ZS, Parikh ND, Planert M, Thormann M, Torzilli G, Solbiati LA, Cho CS. The #HOPE4LIVER Single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors: One-year Update of Clinical Outcomes. Ann Surg. 2025 Dec 1;282(6):908-916. doi: 10.1097/SLA.0000000000006720. Epub 2025 Apr 9.

  PMID: 40201962 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: HistoSonics, Inc.

clinicaltrials@histosonics.com

(877) 740-0543

Study Officials

• Timothy J Ziemlewicz, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Clifford S Cho, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single arm, non-randomized prospective trial.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 1, 2020
• Study Start: January 27, 2021
• Primary Completion: January 9, 2023
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 19, 2025
• Results First Posted: April 11, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)