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RECRUITING
NCT06867315
NA

Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective, Multicentre, Single-Arm Clinical Trial on the Safety and Effectiveness of Transperineal Irreversible Electroporation for the Ablation of Benign Prostatic Hyperplasia

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

99

Start Date

2024-09-11

Completion Date

2027-05-29

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DEVICE

Composite steep-pulse therapeutic device (CNP-III)

Electrodes are inserted percutaneously into the bilateral transition zones of the prostate via a transperineal approach under real-time transrectal ultrasound guidance with a biplane probe; freehand or perineal template placement is permitted by the protocol. A minimum distance of 0.5 cm is maintained from the urethra, the prostatic apex, and the rectum; needle spacing is 1.0-2.2 cm; the effective exposed electrode length is 1.5, 2.0, or 2.5 cm. Ablation is performed in the high-frequency or low-frequency mode, with ablation parameters adjusted according to the delivered current. The ablation range is assessed intraoperatively by contrast-enhanced ultrasound. Procedures are performed under general anaesthesia, neuraxial anaesthesia, or intravenous sedation combined with local anaesthesia. An indwelling urinary catheter is placed before the procedure.

Locations (10)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Quanzhou First Hospital

Quanzhou, Fujian, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Zhangzhou Hospital of Fujian Province

Zhangzhou, Fujian, China

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai Jiading District Central Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China