The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY US)

Brief description of study

This trial is a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors. Data through 90 days for all enrolled subjects will be summarized in a primary analysis to be submitted for Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 14-day, 30-day, 90-day, 180-day and annual time points.


Clinical Study Identifier: s23-00690
ClinicalTrials.gov Identifier: NCT05820087
Principal Investigator: William C Huang.
Other Investigators: James S Wysock, Samir Taneja, Mikhail Silk, Wei Phin Tan.


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