🏛️ Verified NIH Record • Updated 2025-11-13
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (NCT04572633)
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: HistoSonics, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Miami Cancer Institute — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Miami Cancer Institute — Miami, Florida
- Tampa General Hospital — Tampa, Florida
- University of Chicago — Chicago, Illinois
- University of Kansas Medical Center — Kansas City, Kansas
- University of Michigan Hospital — Ann Arbor, Michigan
- University Hospital - UW Health — Madison, Wisconsin
- Medical College of Wisconsin/Froedtert Hospital — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Liver Neoplasms
- Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections — Vancouver, British Columbia
- Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) — Fullerton, California
- Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors — Philadelphia, Pennsylvania
Explore by condition: All Liver Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.