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

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ClinicalTrials.gov Identifier: NCT04573881
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
HistoSonics, Inc.

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE October 5, 2020
Last Update Posted Date October 14, 2022
Actual Study Start Date  ICMJE June 4, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • 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
  • 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 ]
    Safety
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
  • 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
  • Descriptive summary of all reported adverse events. [ Time Frame: 30 days post-index procedure ]
    Safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • 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
  • All adverse events reported within 30 days of the index procedure. [ Time Frame: 30 days post-index procedure ]
    Safety
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2020)		 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER)
Official Title  ICMJE The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Liver Tumor
  • HCC
  • Metastasis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Treatment Group
This is a single arm study that intends to treat all enrolled subject with the histotripsy device.
Intervention: Device: HistoSonics Histotripsy
Publications * Wah TM, Pech M, Thormann M, Serres X, Littler P, Stenberg B, Lenton J, Smith J, Wiggermann P, Planert M, Vidal-Jove J, Torzilli G, Solbiati L. A Multi-centre, Single Arm, Non-randomized, Prospective European Trial to Evaluate the Safety and Efficacy of the HistoSonics System in the Treatment of Primary and Metastatic Liver Cancers (#HOPE4LIVER). Cardiovasc Intervent Radiol. 2022 Nov 15. doi: 10.1007/s00270-022-03309-6. Online ahead of print.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2020)		 45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zoe Secord 612-474-2493 zoe.secord@histosonics.com
Contact: Christine Sullivan 612-474-2493 christine.sullivan@histosonics.com
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04573881
Other Study ID Numbers  ICMJE CSP1473
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party HistoSonics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE HistoSonics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luigi A Solbiati, MD Humanitas Hospital
PRS Account HistoSonics, Inc.
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP