We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER) (#HOPE4LIVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04573881
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : October 14, 2022
Information provided by (Responsible Party):
HistoSonics, Inc.

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.

Condition or disease Intervention/treatment Phase
Liver Tumor HCC Metastasis Device: HistoSonics Histotripsy Not Applicable

Detailed Description:
This trial is a single arm, non-randomized prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Data through the 30-day time point will be used for a Regulatory Submission to the Notified Body. Additionally, subjects will be followed for one (1) year post-index procedure, with evaluations at the 6-month and 1-year time points to estimate the efficacy and safety profile of the HistoSonics System as part of post-market clinical follow-up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This trial is a single arm, non-randomized prospective trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER)
Actual Study Start Date : June 4, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Treatment Group
This is a single arm study that intends to treat all enrolled subject with the histotripsy device.
Device: HistoSonics Histotripsy
The HistoSonics system (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.

Primary Outcome Measures :
  1. Technical success will be determined by evaluating the treatment size and coverage (volume) of the treated tumor via CT or MR imaging. [ Time Frame: ≤36 hours post-index procedure ]
    Technical Efficacy

  2. Index procedure related major complications, defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher toxicities, up to 30 days post index-procedure. [ Time Frame: 30 days post-index procedure ]

Secondary Outcome Measures :
  1. Lack of a nodular or mass-like area of enhancement within or along the edge of the treatment volume [ Time Frame: 30 days post-index procedure ]
    Technique Efficacy

  2. All adverse events reported within 30 days of the index procedure. [ Time Frame: 30 days post-index procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is ≥18 years of age
  2. 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
  3. Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
  4. Subject is able to undergo general anesthesia
  5. Subject has a Child-Pugh Score of A or B (up to B8)
  6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
  7. 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 bilirubin <2.5x 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
  8. Subject has an International Normalized Ratio (INR) score of <2.0 , ≤7 days prior to the index procedure
  9. 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.
  10. The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
  11. Subject has an adequate acoustic window to visualize targeted tumor(s) using ultrasound imaging
  12. 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.

Exclusion Criteria:

  1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period
  2. Subject is enrolled in another investigational trial and/or is taking investigational medication or treated with an investigational device ≤30-days prior to index procedure
  3. 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
  4. Subject has a serum creatinine >2.0 mg/dL or estimated glomerular filtration rate (EGFR) <30, unless on dialysis
  5. Subject has major surgical procedure or significant traumatic injury ≤2 weeks prior to the index procedure or not fully recovered from side effects/complications of such procedure or trauma
  6. Subject has not recovered to common terminology criteria for adverse events (CTCAE) grade 1 or better from any adverse effects (except alopecia) related to previous anti-cancer therapy
  7. Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
  8. Subject has a coagulopathy that is uncorrectable
  9. Subject has a planned cancer treatment (e.g. resection, chemotherapy, etc.) from the index-procedure date and prior to completion of the 30-day follow-up visit
  10. Subject has previous treatment with bevacizumab that has not been discontinued >40 days prior to the planned index-procedure date
  11. Subject has planned bevacizumab treatment prior to completion of the 30-day follow-up visit
  12. Subject has previous treatments with chemotherapy and/or radiotherapy that has not been discontinued ≥2 weeks prior to the planned index-procedure date or has not recovered from related toxicity
  13. Subject has previous treatment with immunotherapies that has not been discontinued ≥4 weeks prior to the index-procedure or has not recovered from related toxicity
  14. Subject has a life expectancy less than six (<6) months
  15. In the opinion of the Investigator, histotripsy is not a treatment option for the subject
  16. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
  17. Subjects' tumor(s) is not treatable by the System's working ranges (refer to User Manual)
  18. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated
  19. Subjects' targeted tumor(s) has/have had prior locoregional therapy (e.g. ablation, embolization, radiation)
  20. Subject is eligible for surgical resection
  21. Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
  22. The targeted tumor(s) is not clearly visible with diagnostic ultrasound and computed tomography (CT) or magnetic resonance (MR) imaging
  23. The targeted tumor(s) is located in liver segment 1
  24. The Planned Treatment Volume intended to cover the targeted tumor includes or encompasses any portion of the main portal vein, common hepatic duct, common bile duct, gallbladder or stomach/bowel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573881

Layout table for location contacts
Contact: Zoe Secord 612-474-2493 zoe.secord@histosonics.com
Contact: Christine Sullivan 612-474-2493 christine.sullivan@histosonics.com

Layout table for location information
Städtisches Klinikum Braunschweig gGmbH Recruiting
Braunschweig, Germany
Contact: Bettina Gerndt       b.gerndt@klinikum-braunschweig.de   
Principal Investigator: Philipp Wiggermann, MD         
Universitätsklinikum Magdeburg Klinik für Radiologie und Nuklearmedizin Recruiting
Magdeburg, Germany, 39120
Contact: Anja Zinke       anga.zinke@med.ovgu.de   
Principal Investigator: Maciej Pech, MD         
Istituto Clinico Humanitas - Humanitas Mirasole S.P.A. Recruiting
Milano, Italy
Contact: Ferrillo Giuseppe       giuseppe.ferrillo@humanitas.it   
Principal Investigator: Luigi A. Solbiati, MD         
Principal Investigator: Gudio Torzilli, MD         
Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Aitor Rodriguez Martinez       aitor.rodriguez@vhebron.net   
Principal Investigator: Xavier Serres, MD         
United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Jonathan Pearce       jonathan.pearce3@nhs.net   
Principal Investigator: Tze Wah, MD         
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Sarah Hogg       sarah.hogg1@nhs.net   
Principal Investigator: Peter Littler, MD         
Sponsors and Collaborators
HistoSonics, Inc.
Layout table for investigator information
Principal Investigator: Luigi A Solbiati, MD Humanitas Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: HistoSonics, Inc.
ClinicalTrials.gov Identifier: NCT04573881    
Other Study ID Numbers: CSP1473
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases