Trial Outcomes & Findings for The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK) (NCT NCT04573881)

Last Updated: 2026-01-12

Results Overview

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. \[Core Laboratory Adjudicated\]

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

24 participants

Primary outcome timeframe

≤36 hours post-index procedure

Results posted on

2026-01-12

Participant Flow

The trial was designed to enroll up to 45 participants; however, enrollment was stopped after 24 participants were enrolled due to completion of the primary analysis of #HOPE4LIVER US (NCT04572633). The primary analysis assessed the primary and secondary endpoints at 30 days using pooled data from #HOPE4LIVER EU/UK and #HOPE4LIVER US after a total of 40 evaluable participants enrolled between the two trials. Follow-up beyond 30 days is ongoing.

Participant milestones

Participant milestones
Measure	HistoSonics System HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Overall Study STARTED	24
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	HistoSonics System HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Overall Study Participant in active follow-up at 30 days	24

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HistoSonics System n=24 Participants HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Age, Continuous	62.9 years STANDARD_DEVIATION 10.0 • n=210 Participants
Sex: Female, Male Female	14 Participants n=210 Participants
Sex: Female, Male Male	10 Participants n=210 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=210 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=210 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants
Race/Ethnicity, Customized White	23 Participants n=210 Participants
Race/Ethnicity, Customized Other	1 Participants n=210 Participants
Type of tumor Hepatocellular carcinoma	7 Participants n=210 Participants
Type of tumor Liver metastasis	17 Participants n=210 Participants

PRIMARY outcome

Timeframe: ≤36 hours post-index procedure

Population: Four tumors had insufficient imaging data for the core laboratory to evaluate technical success.

Outcome measures

Outcome measures
Measure	HistoSonics System n=22 tumors HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Primary Efficacy: Technical Success	100 percentage of tumors Interval 100.0 to 100.0

PRIMARY outcome

Timeframe: 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. \[Clinical Events Committee Adjudicated\]

Outcome measures

Outcome measures
Measure	HistoSonics System n=24 Participants HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Primary Safety: Procedure-Related Major Complications	12.5 percentage of participants Interval 4.3 to 31.0

SECONDARY outcome

Timeframe: 30 days post-index procedure

Population: Five of the 22 tumors analyzed for technical success had missing or insufficient imaging data for the core laboratory to evaluate 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. \[Core Laboratory Adjudicated\]

Outcome measures

Outcome measures
Measure	HistoSonics System n=17 tumors HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Secondary Efficacy: Technique Efficacy	100 percentage of tumors Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 30 days post-index procedure

Number of adverse events (serious and non-serious) reported within 30 days post-index procedure. \[Clinical Events Committee Adjudicated\]

Outcome measures

Outcome measures
Measure	HistoSonics System n=24 Participants HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Secondary Safety: All Adverse Events	38 adverse events

Adverse Events

HistoSonics System

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HistoSonics System n=24 participants at risk HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Hepatobiliary disorders Hepatic failure	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Injury, poisoning and procedural complications Postoperative thrombosis	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Injury, poisoning and procedural complications Procedural pain	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Blood and lymphatic system disorders Splenic haematoma	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Gastrointestinal disorders Melaena/Melena	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
General disorders Chest pain	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Infections and infestations Sepsis	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.

Other adverse events

Other adverse events
Measure	HistoSonics System n=24 participants at risk HistoSonics System: The HistoSonics System - intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Gastrointestinal disorders Abdominal pain	12.5% 3/24 • Number of events 3 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
General disorders Pyrexia	16.7% 4/24 • Number of events 5 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Injury, poisoning and procedural complications Procedural pain	25.0% 6/24 • Number of events 6 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Blood and lymphatic system disorders Anaemia/Anemia	8.3% 2/24 • Number of events 2 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Gastrointestinal disorders Abdominal pain upper	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
General disorders Asthenia	4.2% 1/24 • Number of events 2 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
General disorders Discomfort	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
General disorders Localized oedema	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Injury, poisoning and procedural complications Procedural nausea	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Injury, poisoning and procedural complications Post procedural oedema	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Musculoskeletal and connective tissue disorders Back pain	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Skin and subcutaneous tissue disorders Urticaria	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Metabolism and nutrition disorders Diabetes mellitus	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.
Hepatobiliary disorders Hepatic hypoperfusion	4.2% 1/24 • Number of events 1 • Enrollment through 30 days All adverse events were reported starting at the time the participant was enrolled in the trial to the 1-year visit interval or trial exit (whichever comes first). Data collection for adverse events is still ongoing.

Additional Information

Vice President of Clinical Affairs

HistoSonics, Inc.

Phone: (877) 740-0543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER