An interventional study of Composite steep-pulse therapeutic device (CNP-III) in Benign Prostatic Hyperplasia, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 10 sites in China. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment
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:
Participants will be asked to:
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 99 is close to the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transrectal ultrasound-guided transperineal irreversible electroporation using the composite steep-pulse therapeutic device (CNP-III; Zhejiang CuraWay Medical Technology Co., Ltd., Hangzhou, China).
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.
Also known as: steep pulse therapy system, CNP-III
The change in maximum urinary flow rate
compare the maximum urinary flow rate of the patients post treatment to the baseline level of the patients
Time frame: 3 months
changes in IPSS，QoL, ICIQ, PV, PVR at 1 and 3 months postoperatively
compare the IPSS，QoL, ICIQ, PV, PVR at 1 and 3 months after treatment with baseline
Time frame: baseline, 1 month and 3 months
Started Sep 2024 (actual). Primary completion is estimated for May 2027, 32 months after the start.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 32 months is above that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 14, 2026: start May 2024 → Sep 2024, primary completion May 2026 → May 2027 and completion May 2026 → May 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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No contact was published for this record. The registry link below has the sponsor’s details.
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First Affiliated Hospital of Zhejiang University →