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Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 29, 2026 → May 29, 2027
See other at-risk trials from First Affiliated Hospital of Zhejiang University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 29, 2026 to May 29, 2027 Show 9 more changesShow less
    • Enrollment increased: 10 → 99 participants
    • Start date: May 29, 2024 to Sep 11, 2024
    • Trial sites expanded: 1 → 10 locations
    • Interventions modified
    • Trial arms changed: 2 → 1
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoint revised
    • Collaborators: 4 to 9
    • Study title shortened, about 9 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06867315
Lead Sponsor First Affiliated Hospital of Zhejiang University
Collaborators: Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital of University of Science and Technology of China, First People's Hospital of Hangzhou, Fujian Provincial Hospital, Zhongshan Hospital Xiamen University, Quanzhou First Hospital, Shanghai 10th People's Hospital, Shanghai Jiading District Central Hospital, Zhangzhou Municipal Hospital of Fujian Province
Conditions
(from sponsor)		 Benign Prostatic Hyperplasia
Related terms Lower Urinary Tract Symptoms, Prostatic Hyperplasia
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov