No phaseRecruitingAge-related condition
Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia
Prospective, Multicentre, Single-Arm Clinical Trial on the Safety and Effectiveness of Transperineal Irreversible Electroporation for the Ablation of Benign Prostatic Hyperplasia
- Sponsor
- First Affiliated Hospital of Zhejiang University (Academic or other)
- Enrolment
- 99 planned
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Composite steep-pulse therapeutic device (CNP-III)
- Ages
- adults, older adults
- Registry
- NCT06867315
Full record on ClinicalTrials.gov
From the registry
This clinical trial focuses on men with benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate causes urinary problems. The goal is to test a non-thermal ablation technique called irreversible electroporation (IRE), delivered with a steep pulse therapy system, for treating BPH. The main questions it aims to answer are: 1. How many participants have improved urine flow 3 months after treatment? 2. How do urinary symptoms, quality of life, and prostate size change after treatment? 3. What side effects occur, and how serious are they? Participants will be asked to: * undergo the IRE procedure: needle electrodes are placed in the prostate through the perineum under ultrasound guidance, and short electric pulses ablate the enlarged tissue; * attend follow-up visits at 1 and 3 months after the procedure for urine flow tests, symptom questionnaires, and ultrasound measurements.
Primary outcomes
- The change in maximum urinary flow rate
History
Primary completion expected
Last registry update
Registered
Started