At a glance
ClinicalIndex Comparison RecordN/AActive· 47 enrolled
Drug / intervention
HistoSonics Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)
In Brief
A clinical study evaluating HistoSonics System for Liver Neoplasms and 2 related conditions. Active but no longer recruiting, targeting 47 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Neoplasms, Hepatocellular Carcinoma, Liver Metastases
CountriesUnited States
Collaborators--
Timeline
N/AActive
2021202220232024202520262027
First PostedOct 2020
Enrollment StartJan 2021
Primary CompletionJan 2023
TodayJul 2026
Study CompletionSep 2027
First PostedOct 1, 2020
Enrollment StartJan 27, 2021
Primary CompletionJan 9, 2023
Study CompletionSep 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.8 years ago
Interventions
HistoSonics Systemdevice
The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.