NCT05820087

The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)

The HistoSonics Edison System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY US)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Renal Cancer
• Tumor, Solid
• Kidney Cancer
• Tumor
• Tumor, Benign

Interventions

Type	Name	Description
DEVICE	HistoSonics Edison System	Non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.

Timeline

• Start date: 2024-01-04
• Primary completion: 2025-09-04
• Completion: 2030-07-01
• First posted: 2023-04-19
• Last updated: 2025-12-22

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study