Liver Neoplasms#HOPE4LIVERNCT04573881
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK)
A study testing HistoSonics System in people with Liver Neoplasms and Hepatocellular Carcinoma, run by HistoSonics, Inc. at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Hepatocellular Carcinoma, Liver Metastases
- What is being tested?
- HistoSonics System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 4 Jun 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 that is an HCC patient must have a targetable lesion(s) which meets the United Network for Organ Sharing and Organ Procurement and Transplantation Network (UNOS-OPTN) class 5 diagnostic criteria for HCC
- Subject that is diagnosed with liver metastases must have prior diagnosis of primary tumor or metastatic tumor to identify the primary cancer type. Subjects must have untreated new or growing liver tumor(s) radiologically consistent with metastases. Note: A biopsy is required to confirm metastatic disease and the pathological results must be obtained prior to the index procedure (does not need to be a targeted tumor(s))
- Subject is able to undergo general anesthesia
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- Subject has a Child-Pugh Score of A or B (up to B8)
- 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 planned index-procedure date:
- Liver function: Alanine transaminase (ALT) <2.5x upper limit of normal (ULN) and Aspartate transaminase (AST) <2.5x ULN and 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 planned index procedure date
- 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.
- Note: If the subject is treated with surgical resection prior to the index procedure, the resection must be performed ≥2 weeks prior to the planned index-procedure date
Who cannot join
- 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
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- Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
- Subject has a 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 planned index-procedure date 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
- Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
- Subjects' tumor(s) is not treatable by the System's working ranges (refer to User Manual)
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated
- Subjects' targeted tumor(s) has/have had prior locoregional therapy (e.g. ablation, embolization, radiation)
- Subject is eligible for surgical resection
- Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
- The targeted tumor(s) is not clearly visible with diagnostic ultrasound and computed tomography (CT) or magnetic resonance (MR) imaging
- The targeted tumor(s) is located in liver segment 1
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany2 sites
Städtisches Klinikum Braunschweig gGmbH
Braunschweig
Universitätsklinikum Magdeburg Klinik für Radiologie und Nuklearmedizin
Magdeburg, 39120
United Kingdom2 sites
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN
About this study
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.
Read the detailed description
This trial is a single arm, non-randomized, multicenter, 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. Additionally, subjects will be evaluated at 6 months and followed annually for up to five (5) years post-index procedure.
- Conditions
- Liver Neoplasms, Hepatocellular Carcinoma, Liver Metastases
- Being tested
- HistoSonics System
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoSonics SystemDevice
Also called Histotripsy
The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| HistoSonics System | Experimental | Not described Receives: Device: HistoSonics System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: ≤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]
Measured: 30 days post-index procedure
Secondary outcomes (2)
Secondary Efficacy: Technique Efficacy
Technique efficacy, defined as the lack of a nodular or mass-like area of enhancement within or along the edge of the treatment volume assessed via CT or MR imaging at 30-days post-procedure. [Core Laboratory Adjudicated]
Measured: 30 days post-index procedure
Secondary Safety: All Adverse Events
Number of adverse events (serious and non-serious) reported within 30 days post-index procedure. [Clinical Events Committee Adjudicated]
Measured: 30 days post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start4 Jun 2021
- Primary completion29 Sep 2022
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is a single arm, non-randomized, multicenter, prospective trial.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HistoSonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi A Solbiati, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573881
- Sponsor's protocol ID
- CSP1473
- Acronym
- #HOPE4LIVER
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2020
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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. 2023 Feb;46(2):259-267. doi: 10.1007/s00270-022-03309-6. Epub 2022 Nov 15.
PubMed 36380155Mendiratta-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.
PubMed 39225612Ziemlewicz 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.
PubMed 40201962Wong BO, Fan CM, Shyn PB, Wang J. Vascular complications following histotripsy of hepatocellular carcinoma. Int J Hyperthermia. 2025 Dec;42(1):2603108. doi: 10.1080/02656736.2025.2603108. Epub 2025 Dec 16.
PubMed 41403239
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK)
- ClinicalTrials.gov ID
- NCT04573881
- Acronym / sponsor ID
- #HOPE4LIVER / CSP1473
- Conditions
- Liver Neoplasms, Hepatocellular Carcinoma, Liver Metastases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HistoSonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, multicenter, 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. Additionally, subjects will be evaluated at 6 months and followed annually for up to five (5) years post-index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is a single arm, non-randomized, multicenter, prospective trial.
| Arm | Type | Receives |
|---|---|---|
| HistoSonics System | Experimental | Device: HistoSonics System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 (up to B8)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistoSonics SystemAlso: HistotripsyThe HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound. | Device | HistoSonics System |
Primary outcome
Primary Efficacy: Technical Success
Time frame: ≤36 hours post-index procedure
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 Safety: Procedure-Related Major Complications
Time frame: 30 days post-index procedure
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]
2 secondary outcomes
Secondary Efficacy: Technique Efficacy
Time frame: 30 days post-index procedure
Secondary Safety: All Adverse Events
Time frame: 30 days post-index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36380155Wah 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. 2023 Feb;46(2):259-267. doi: 10.1007/s00270-022-03309-6. Epub 2022 Nov 15.
- Results publication: PubMed 39225612Mendiratta-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.
- Results publication: PubMed 40201962Ziemlewicz 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.
- Derived from this study: PubMed 41403239Wong BO, Fan CM, Shyn PB, Wang J. Vascular complications following histotripsy of hepatocellular carcinoma. Int J Hyperthermia. 2025 Dec;42(1):2603108. doi: 10.1080/02656736.2025.2603108. Epub 2025 Dec 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi A Solbiati, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HistoSonics System in people with Liver Neoplasms and Hepatocellular Carcinoma, run by HistoSonics, Inc. at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United Kingdom, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy: Technical Success (time frame: ≤36 hours post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573881, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.