Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04572633 · ClinicalTrials.gov registry record · NA
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy
A NA study of Hepatocellular Carcinoma and Liver Metastases, sponsored by HistoSonics.
- Active
- Registry status
- NA
- Development phase
- 47
- Enrollment target
- 7
- Study locations
NCT04572633: Active NA study of Hepatocellular Carcinoma and Liver Metastases, sponsored by HistoSonics.
NCT04572633 is a NA study of Hepatocellular Carcinoma and Liver Metastases that is active but no longer recruiting, run by HistoSonics. The registered enrollment target is 47 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (82% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572633, a NA study of Hepatocellular Carcinoma and Liver Metastases, is active but no longer recruiting, sponsored by HistoSonics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Technical success, defined as the treatment volume/treatment dimensions being greater than or equal to the targeted tumor, and with complete tumor coverage, via computed tomography (CT) or magnetic resonance (MR) imaging. \[Core Laboratory Adjudicated\] Primary efficacy was assessed per tumor with a performance goal of greater than 70%. Primary efficacy was assessed after the first forty (40) consecutive evaluable subjects were enrolled. Evaluable subjects had sufficient CT or MR imaging data t
Conditions Studied
Interventions
- DEVICE HistoSonics System
Study Locations (7)
Florida
- Miami Cancer Institute - Miami
- Tampa General Hospital - Tampa
Wisconsin
- University Hospital - UW Health - Madison
- Medical College of Wisconsin/Froedtert Hospital - Milwaukee
Illinois
- University of Chicago - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2027-09 |
| Phase | NA |
What the registry record for NCT04572633 still lists
NCT04572633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which HistoSonics System is the first listed.
NCT04572633 lists 7 locations in 5 states (Florida, Wisconsin, Illinois).
Frequently Asked Questions
What is clinical trial NCT04572633 about?
NCT04572633 is a clinical study titled "The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy". 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...
What is the current status of trial NCT04572633?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 47 participants. The study started on 2021-01-27. Estimated completion is 2027-09.
What conditions does trial NCT04572633 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Liver Metastases, Liver Neoplasms.
What interventions are being tested in trial NCT04572633?
The interventions under investigation include: HistoSonics System (DEVICE).
Who is sponsoring clinical trial NCT04572633?
This trial is sponsored by HistoSonics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572633 being conducted?
This trial has 7 study locations across Florida, Illinois, Kansas, Michigan, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04572633's enrollment target sits among peer trials
47 87th of 145 higher than 59 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Targeted Navigation in Hepatocellular Carcinoma (HCC)
RECRUITING · NA
-
Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
RECRUITING · NA
-
HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer
RECRUITING · NA
-
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
RECRUITING · NA
-
Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
RECRUITING · NA
-
CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI