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

NCT04572633 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-11-19

Study results available
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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. The co-primary safety and efficacy endpoints must be met for the trial to be successful.

Conditions

Interventions

DEVICE

HistoSonics System

The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.

Sponsors & Collaborators

  • HistoSonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy J Ziemlewicz, MD · University of Wisconsin, Madison

  • Clifford S Cho, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2023-01-09
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572633 on ClinicalTrials.gov