NCT05432232

The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

Detailed description

This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.

Conditions

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

Interventions

Type	Name	Description
DEVICE	HistoSonics Investigational System	The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.

Timeline

• Start date: 2023-03-23
• Primary completion: 2024-12-28
• Completion: 2025-06-06
• First posted: 2022-06-27
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study