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

Sponsor
HistoSonics, Inc.
Study ID
NCT07214675
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HistoSonics Edison System — DEVICE
    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.

Study Details

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

Key Dates

Start date
Mar 20, 2026
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HistoSonics Edison System

Primary Outcome Measure

Number of Index-Procedure Related Adverse Events Classified by Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 30 days post histotripsy procedure ]

Central Contacts

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