NCT04572633

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

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is a single arm, non-randomized, multicenter, prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Additionally, subjects will be evaluated at 6 months and followed annually for up to five (5) years post-index procedure. The #HOPE4LIVER US trial required pooling data from #HOPE4LIVER US and #HOPE4LIVER EU/UK (NCT04573881). Subjects were treated with the same intervention (HistoSonics System) using identical protocols tailored to the regulatory requirements for each geography.

Conditions

• Liver Neoplasms
• Hepatocellular Carcinoma
• Liver Metastases

Interventions

Type	Name	Description
DEVICE	HistoSonics System	The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.

Timeline

• Start date: 2021-01-27
• Primary completion: 2023-01-09
• Completion: 2027-09-01
• First posted: 2020-10-01
• Last updated: 2025-11-19
• Results posted: 2024-04-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study