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Procedure

Histotripsy with HistoSonics System for Liver Cancer (#HOPE4LIVER US Trial)

N/A
Waitlist Available
Led By Timothy J Ziemlewicz, MD
Research Sponsored by HistoSonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Renal function: serum creatinine <2x ULN
Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ≤36 hours post-index procedure
Awards & highlights

#HOPE4LIVER US Trial Summary

This trial is to see if a new system for treating liver tumors is effective and safe.

Who is the study for?
This trial is for adults with primary liver cancer or liver metastases who haven't had success with other treatments. They must have good liver, kidney, and blood function, no more than three tumors each ≤3cm in size, and be fit enough for general anesthesia. Pregnant women or those on certain recent treatments are excluded.Check my eligibility
What is being tested?
The HistoSonics System's safety and effectiveness in treating liver tumors using Histotripsy—a non-invasive technique—are being tested. Participants will undergo this single-arm treatment to see how well it works against their tumors.See study design
What are the potential side effects?
Potential side effects of the HistoSonics Histotripsy may include pain at the treatment site, bruising, bleeding, inflammation around the treated area, and possible damage to nearby tissues or organs.

#HOPE4LIVER US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal, with creatinine levels less than twice the upper limit.
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I have been diagnosed with liver cancer or cancer that has spread to my liver.
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My tumor is 3 cm or smaller.
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I can safely be put under general anesthesia.
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My liver function is mild to moderately impaired.
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I can take care of myself and am up and about more than half of the day.
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I have up to 3 tumors eligible for histotripsy treatment.
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My liver, kidney, and blood tests are within required ranges.
Select...
My liver tests are within normal limits.

#HOPE4LIVER US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~≤36 hours post-index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and ≤36 hours post-index procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy: Technical Success
Primary Safety: Procedure-Related Major Complications
Secondary outcome measures
Procedure-Related Major Complications
Secondary Efficacy: Technique Efficacy
Secondary Safety: All Adverse Events
+1 more

#HOPE4LIVER US Trial Design

1Treatment groups
Experimental Treatment
Group I: HistoSonics SystemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

HistoSonics, Inc.Lead Sponsor
7 Previous Clinical Trials
198 Total Patients Enrolled
Timothy J Ziemlewicz, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
Clifford S Cho, MDPrincipal InvestigatorUniversity of Michigan

Media Library

Liver Cancer Research Study Groups: HistoSonics System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still ongoing?

"Affirmative. The information on clinicaltrials.gov establishes that this medical trial is actively recruiting patients, with the initial post being made on January 27th 2021 and last updated September 6th 2022. 45 people need to be sourced from seven separate sites for participation in the study."

Answered by AI

In what areas is this scientific experiment being conducted?

"Enrolment is underway at 7 sites, including the Medical College of Wisconsin/Froedtert Hospital in Milwaukee, Tampa General Hospital in Tampa and Miami Cancer Institute in Miami. Other medical centres are also participating."

Answered by AI

How many participants are actively involved in this clinical experiment?

"HistoSonics, Inc. must enroll 45 eligible patients across two different clinical sites: Medical College of Wisconsin/Froedtert Hospital in Milwaukee and Tampa General Hospital in Florida."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy
2021. "The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572633.
All > Liver Fibrosis > Liver Cancer
~11 spots leftby Apr 2025
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