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

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. Identifier: NCT04572633
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : January 28, 2021
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 FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 6-month and annual time points to estimate the efficacy and safety profile of the HistoSonics System.

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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 US)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Treatment Group
This is a single are arm study that intends to treat all enrolled subjects 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 as determined, at ≤36 hours post-index procedure, by evaluating the histotripsy treatment size and coverage. [ 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 areas 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.

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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
  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/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
  8. Subject has an International Normalized Ratio (INR) score of <2.0 , ≤7 days prior to the index procedure
  9. The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
  10. Subject has an adequate acoustic window to visualize targeted tumor(s) using ultrasound imaging
  11. 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 bleeding disorders (e.g. von Willebrand disease) or subject is suspected to have a bleeding disorder
  8. Subject has uncorrectable coagulopathy
  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. Subject has had prior locoregional therapy (e.g. ablation, embolization, radiation) on the targeted tumor(s)
  20. Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
  21. The targeted tumor(s) is not clearly visible with diagnostic ultrasound and computed tomography (CT) or magnetic resonance (MR) imaging
  22. The targeted tumor(s) is located in liver segment 1
  23. 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 identifier (NCT number): NCT04572633

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Contact: Zoe Secord 763-300-7313
Contact: Christine Sullivan 651-398-7586

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United States, Florida
Miami Cancer Institute Not yet recruiting
Miami, Florida, United States, 33176
Contact: Ernesto Cue Barroso   
Principal Investigator: Govindarajan Narayanan, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Ashley Bader   
Contact: Patricia Sanchez   
Principal Investigator: Clifford Davis, MD         
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Pamela Lofton, RN   
Principal Investigator: Osmanuddin Ahmed, MD         
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Carissa Walter   
Principal Investigator: Zach Collins, MD         
United States, Michigan
University of Michigan Hospital Not yet recruiting
Ann Arbor, Michigan, United States, 48109-5030
Contact: Ashley Cawthon   
Principal Investigator: Mishal Mendiratta-Lala, MD         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Laura Brumleve   
Principal Investigator: Shamar Young, MD         
United States, Wisconsin
University Hospital - UW Health Not yet recruiting
Madison, Wisconsin, United States, 53792-3252
Contact: Philip A Danzer   
Principal Investigator: Lori Mankowski Gettle, MD         
Medical College of Wisconsin/ Froedtert Hospital Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Dawn Bolser   
Principal Investigator: Sarah White, MD         
Sponsors and Collaborators
HistoSonics, Inc.
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Principal Investigator: Timothy J Ziemlewicz, MD University of Wisconsin, Madison
Principal Investigator: Clifford S Cho, MD University of Michigan
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Responsible Party: HistoSonics, Inc. Identifier: NCT04572633    
Other Study ID Numbers: CSP1427
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by HistoSonics, Inc.:
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases