Wolverine - Revision A
Research type
Research Study
Full title
The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) using Histotripsy.
IRAS ID
364597
Contact name
Kelly Erickson
Contact email
Sponsor organisation
HistoSonics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The study is designed to evaluate the safety of HistoSonics Histotripsy System for treatment of Benign Prostatic Hyperplasia (BPH). BPH is a common problem among older males that negatively impacts quality of life and results in considerable medical intervention and expense. Minimally invasive BPH therapies including mechanical, thermal ablation, laser, implants, and embolization therapy are becoming more common. Histotripsy has been developed as a promising potential non-invasive, non-thermal mechanism of action, image-guided local treatment method that may overcome of the limitations of ablation technologies. Histotripsy, is a technology that destroys targeted tissue through the precise targeting of acoustic cavitation. This procedure, in contrast to other minimally invasive BPH methods, does not require insertion of cytoscopes or needle electrodes into the urethra to access target prostate tissue. Pulsed sound energy is externally applied through the intact abdomen of patients.
The study will enroll a total of approximately 80 participants who are 50 years old of age or older with a diagnosis of BPH, targeting a maximum of 20 patients treated at up to two clinical sites (Imperial College London & Imperial College Healthcare NHS trust in the United Kingdom and the Chinese University of Hong Kong in China). The duration of this study is expected to be approximately 18 months with the expectation to include the first patient in March 2026 and to complete the study follow-up visits by October 2027.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
26/WM/0008
Date of REC Opinion
16 Mar 2026
REC opinion
Further Information Favourable Opinion