Trial Outcomes & Findings for The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy (NCT NCT05432232)

Last Updated: 2025-12-02

Results Overview

Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). \[Core Lab Adjudicated\]

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Up to 36 hours after the index procedure

Results posted on

2025-12-02

Participant Flow

The trial enrolled participants between March 2023 and November 2024 at one (1) UK site. All eligible subjects who provided informed consent were considered enrolled. Only subjects enrolled and treated with the HistoSonics Investigational System were assessed for the primary endpoints. Follow-up beyond 30 days was ongoing at the time of primary endpoint analysis.

Participant milestones

Participant milestones
Measure	HistoSonics Investigational System The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Participant Screening STARTED	20
Participant Screening Screen Failures	9
Participant Screening COMPLETED	11
Participant Screening NOT COMPLETED	9
Treatment to 30-Day Follow-up STARTED	11
Treatment to 30-Day Follow-up COMPLETED	11
Treatment to 30-Day Follow-up NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HistoSonics Investigational System n=11 Participants The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Age, Continuous	71.0 years n=9 Participants
Sex: Female, Male Female	4 Participants n=9 Participants
Sex: Female, Male Male	7 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race/Ethnicity, Customized White	10 Participants n=9 Participants
Race/Ethnicity, Customized Other	1 Participants n=9 Participants

PRIMARY outcome

Timeframe: Up to 36 hours after the index procedure

Outcome measures

Outcome measures
Measure	HistoSonics Investigational System n=11 tumors The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Primary Effectiveness: Technical Success	100.0 percentage of tumors Interval 71.5 to 100.0

PRIMARY outcome

Timeframe: 30 days Post-Index Procedure

Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. \[Clinical Events Committee Adjudicated\]

Outcome measures

Outcome measures
Measure	HistoSonics Investigational System n=11 Participants The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Primary Safety: Freedom From Index Procedure Related Major Complications	90.9 percentage of participants Interval 58.7 to 99.8

SECONDARY outcome

Timeframe: 90 days Post-Index Procedure

Percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure without repeat Histotripsy \[Core Lab Adjudicated\]

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days Post-Index Procedure

Percentage of targeted tumors successfully eradicated post-index procedure assessed via MRI or CT at 90-days post-index procedure after repeat Histotripsy \[Core Lab Adjudicated\]

Outcome measures

Outcome data not reported

Adverse Events

HistoSonics Investigational System

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HistoSonics Investigational System n=11 participants at risk The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Injury, poisoning and procedural complications Urinary retention postoperative	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Respiratory, thoracic and mediastinal disorders Emphysema	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.

Other adverse events

Other adverse events
Measure	HistoSonics Investigational System n=11 participants at risk The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Blood and lymphatic system disorders Neutropenia	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Gastrointestinal disorders Constipation	36.4% 4/11 • Number of events 4 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Gastrointestinal disorders Vomiting	27.3% 3/11 • Number of events 3 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Gastrointestinal disorders Abdominal pain lower	18.2% 2/11 • Number of events 2 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Gastrointestinal disorders Intestinal dilatation	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
General disorders Influenza like illness	27.3% 3/11 • Number of events 3 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
General disorders Pain	18.2% 2/11 • Number of events 3 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
General disorders Decreased appetite	18.2% 2/11 • Number of events 2 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
General disorders Pyrexia	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Infections and infestations Upper aerodigestive tract infection	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Injury, poisoning and procedural complications Procedural pain	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Injury, poisoning and procedural complications Procedural site reaction	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Investigations White blood cell count increased	18.2% 2/11 • Number of events 2 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Investigations C-reactive protein increased	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Metabolism and nutrition disorders Hyponatraemia	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Musculoskeletal and connective tissue disorders Back pain	36.4% 4/11 • Number of events 4 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Nervous system disorders Headache	18.2% 2/11 • Number of events 2 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Nervous system disorders Taste disorder	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Renal and urinary disorders Haematuria	90.9% 10/11 • Number of events 10 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Renal and urinary disorders Flank pain	18.2% 2/11 • Number of events 3 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Renal and urinary disorders Chromaturia	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Renal and urinary disorders Subcapsular renal haematoma	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Skin and subcutaneous tissue disorders Hypoaesthesia	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Number of events 1 • Histotripsy treatment through 30 days All adverse events reported starting at the time the participant was treated in the trial to the 30-day visit interval.

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