Clinical Trial

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

Study acronym: #HOPE4LIVER US
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 29 amendments
This ClinicalTrials.gov record has been amended 29 times since 2020-09-28; most recent amendment 2025-11-13.
Status change: Recruiting → Active, Not Recruiting 2023-06-26
Status change: Not Yet Recruiting → Recruiting 2021-01-26
Trial Details
NCT Number NCT04572633
Lead Sponsor HistoSonics, Inc.
Conditions Liver Neoplasms, Hepatocellular Carcinoma, Liver Metastases
Enrollment 47 participants
Start Date 2021-01-27
Primary Completion 2023-01-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-19