NCT07214675

The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: HistoSonics, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.

Detailed description

This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Histotripsy System for treatment of BPH. Following histotripsy, subjects will undergo imaging ≤ 72 hours post-index procedure. Additionally, subjects will be followed at 30-day, 90-day and 180-day timepoints.

Conditions

• Benign Prostatic Hyperplasia

Interventions

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

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-05-01
• Completion: 2027-10-01
• First posted: 2025-10-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study