Trial Outcomes & Findings for The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (NCT NCT04572633)

NCT ID: NCT04572633

Last Updated: 2025-11-19

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. \[Core Laboratory Adjudicated\] Primary efficacy was assessed per tumor with a performance goal of greater than 70%. Primary efficacy was assessed after the first forty (40) consecutive evaluable subjects were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: ≤36 hours post-index procedure
• Results posted on: 2025-11-19

Participant Flow

As the #HOPE4LIVER EU/UK and #HOPE4LIVER US trials were developed with an identical study design using the same device, the data from all 47 participants enrolled were pooled for analysis. The pooled data contains 23 participants treated in the US and 24 participants treated in Europe. Data from the first 44/47 participants enrolled were analyzed for primary effectiveness and primary safety. Follow-up beyond 30 days is ongoing.

Participant milestones

Measure	HistoSonics System HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Overall Study STARTED	47
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Measure	HistoSonics System HistoSonics System: The HistoSonics System (System) is 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	47

Baseline Characteristics

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy

Baseline characteristics by cohort

Measure	HistoSonics System n=47 Participants HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Age, Continuous	63.0 years STANDARD_DEVIATION 12.77
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race/Ethnicity, Customized Black or African American	1 Participants
Race/Ethnicity, Customized White	45 Participants
Race/Ethnicity, Customized Other	1 Participants
Type of tumor Hepatocellular carcinoma	19 Participants
Type of tumor Liver metastasis	28 Participants

PRIMARY outcome

Timeframe: ≤36 hours post-index procedure

Population: Primary efficacy was assessed after the first forty (40) consecutive evaluable subjects were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate 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] Primary efficacy was assessed per tumor with a performance goal of greater than 70%.

Primary efficacy was assessed after the first forty (40) consecutive evaluable subjects were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success.

Outcome measures

Measure	HistoSonics System n=44 tumors HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Primary Efficacy: Technical Success	95.5 percentage of tumors Interval 83.72 to 100.0

PRIMARY outcome

Timeframe: 30 days post-index procedure

Population: Primary safety was assessed on all subjects enrolled, after the first forty (40) consecutive subjects evaluable for technical success were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success. Enrollment of 44 total subjects was required to assess forty (40) subjects evaluable for technical success.

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] Primary safety was assessed per participant with a performance goal of less than 25%.

Primary safety was assessed on all subjects enrolled, after the first forty (40) consecutive subjects evaluable for technical success were enrolled. Evaluable subjects had sufficient CT or MR imaging data to allow the independent core laboratory to evaluate technical success. Enrollment of 44 total subjects was required to assess forty (40) subjects evaluable for technical success.

Outcome measures

Measure	HistoSonics System n=44 Participants HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Primary Safety: Procedure-Related Major Complications	6.8 percentage of participants Interval 2.35 to 18.23

SECONDARY outcome

Timeframe: ≤36 hours post-index procedure

Population: Five tumors had insufficient imaging data for the core laboratory to evaluate 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]

Outcome measures

Measure	HistoSonics System n=47 tumors HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Technical Success	95.7 percentage of tumors Interval 84.78 to 100.0

SECONDARY 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

Measure	HistoSonics System n=47 Participants HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Procedure-Related Major Complications	6.4 percentage of participants Interval 2.19 to 17.16

SECONDARY outcome

Timeframe: 30 days post-index procedure

Population: Six of the 47 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

Measure	HistoSonics System n=41 tumors HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Secondary Efficacy: Technique Efficacy	82.9 percentage of tumors Interval 68.29 to 92.5

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

Measure	HistoSonics System n=47 Participants HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Secondary Safety: All Adverse Events	108 adverse events

Adverse Events

HistoSonics System

Serious events: 9 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	HistoSonics System n=47 participants at risk HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Hepatobiliary disorders Hepatic failure	2.1% 1/47 • 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 Portal vein thrombosis	2.1% 1/47 • 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	2.1% 1/47 • 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	2.1% 1/47 • 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	2.1% 1/47 • 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	2.1% 1/47 • 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	2.1% 1/47 • 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	2.1% 1/47 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	2.1% 1/47 • 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	2.1% 1/47 • 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

Measure	HistoSonics System n=47 participants at risk HistoSonics System: The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
Gastrointestinal disorders Abdominal pain	23.4% 11/47 • Number of events 11 • 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 distension	4.3% 2/47 • 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	4.3% 2/47 • 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 Constipation	4.3% 2/47 • 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 Vomiting	4.3% 2/47 • 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 Eructation	2.1% 1/47 • 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 Inguinal hernia	2.1% 1/47 • 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 Pyrexia	12.8% 6/47 • Number of events 7 • 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 Fatigue	10.6% 5/47 • 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.
General disorders Pain	2.1% 1/47 • 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	2.1% 1/47 • 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 Chest discomfort	2.1% 1/47 • 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	2.1% 1/47 • 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 Discomfort	2.1% 1/47 • 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	2.1% 1/47 • 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	23.4% 11/47 • Number of events 11 • 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	4.3% 2/47 • 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.
Injury, poisoning and procedural complications Post procedural discomfort	2.1% 1/47 • 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	2.1% 1/47 • 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 Atelectasis	8.5% 4/47 • Number of events 4 • 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 Cough	2.1% 1/47 • 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	2.1% 1/47 • 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 Oropharyngeal pain	2.1% 1/47 • 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 Pleural effusion	2.1% 1/47 • 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	8.5% 4/47 • Number of events 4 • 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	4.3% 2/47 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.1% 1/47 • 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 Rash	4.3% 2/47 • 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.
Skin and subcutaneous tissue disorders Night sweats	2.1% 1/47 • 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	2.1% 1/47 • 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.
Investigations Blood alkaline phosphatase increased	2.1% 1/47 • 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.
Investigations Gamma-glutamyltransferase increased	2.1% 1/47 • 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.
Investigations Liver function test abnormal	2.1% 1/47 • 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.
Investigations Respiratory rate increased	2.1% 1/47 • 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.
Investigations White blood cell count increased	2.1% 1/47 • 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 Anaemia/Anemia	6.4% 3/47 • 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.
Cardiac disorders Atrial fibrillation	2.1% 1/47 • 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.
Cardiac disorders Palpitations	2.1% 1/47 • 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.
Cardiac disorders Pericardial effusion	2.1% 1/47 • 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 Decreased appetite	4.3% 2/47 • 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.
Metabolism and nutrition disorders Diabetes mellitus	2.1% 1/47 • 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	4.3% 2/47 • 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.
Infections and infestations COVID-19	2.1% 1/47 • 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 Gastroenteritis viral	2.1% 1/47 • 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.
Nervous system disorders Headache	2.1% 1/47 • 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.
Nervous system disorders Sinus headache	2.1% 1/47 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	2.1% 1/47 • 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.
Psychiatric disorders Apathy	2.1% 1/47 • 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.
Reproductive system and breast disorders Balanoposthitis	2.1% 1/47 • 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.
Vascular disorders Vascular pseudoaneurysm	2.1% 1/47 • 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: clinicaltrials@histosonics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER