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Clinical Trial Summary

The purpose of this trial is to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05820087
Study type Interventional
Source HistoSonics, Inc.
Contact Amber Dickson
Phone 612-351-0361
Email amber.dickson@histosonics.com
Status Recruiting
Phase N/A
Start date January 4, 2024
Completion date December 2029

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