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

NCT07214675 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-09

No results posted yet for this study

Summary

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

Conditions

  • Benign Prostatic Hyperplasia

Interventions

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.

Sponsors & Collaborators

  • HistoSonics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2027-05-31
Completion
2027-10-31
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214675 on ClinicalTrials.gov