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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04573881
Study type Interventional
Source HistoSonics, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date June 4, 2021
Completion date July 2026

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