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

Brief description of study

This study is testing the HistoSonics Edison System for treating kidney tumors using histotripsy (involves using focused ultrasound beams from outside the body to create tiny bubbles that burst and break apart cancer tissue, turning it into small pieces without the need for surgery or cutting). It's designed to confirm the HistoSonics Edison System's effectiveness in treating kidney tumors before it becomes available in the market. The target population includes patients aged 22 or older with a single kidney tumor up to 3cm in size. The trial is expected to last about 7 years, including an enrollment phase of around 18 months and follow-up for up to five years after the procedure. The trial is designed this way because there's limited data on kidney tumor treatments, and this approach helps ensure patient safety while evaluating the new treatment's effectiveness.

Clinical Study Identifier: s23-00690
Principal Investigator: William C Huang.

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