Benign Prostatic HyperplasiaNCT06867315
Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia
A study testing Composite steep-pulse therapeutic device (CNP-III) in people with Benign Prostatic Hyperplasia, run by First Affiliated Hospital of Zhejiang University at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Composite steep-pulse therapeutic device (CNP-III)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 10 sitesChina
- Study dates
- 11 Sep 2024to 29 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate.
- international prostate symptom score(IPSS)>=12.
- Maximum urinary flow rate between >5ml/s and <15ml/s with a minimum voided volume ≥ 150ml.
- Age ≥ 50 years old.
- Subjects are willing to participate and have signed the informed consent form.
Who cannot join
- Patients with acute or severe urinary tract infections.
- Patients clinically diagnosed with prostate cancer.
- Patients with neurogenic bladder or bladder dysfunction due to other factors.
- Patients with urethral stricture.
- Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery.
- Patients with implanted pacemakers or metal replacements in the pelvis or hip joints.
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- Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons.
- Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up.
- Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment.
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350
Ning Lin, MD, +86-138-6063-9236, 13860639236@163.com
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Tian'an Jiang, PhD, 86-18857127666, tiananjiang@126.com
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310
Jianhua Fang, MD, +86-180-5876-5837, fjh173@163.com
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230
Jun Xiao, MD, +86-189-0051-8346, xiaojun0551@126.com
- Recruiting
Quanzhou First Hospital
Quanzhou, Fujian, 362
Zhiyang Huang, MD, +86-139-0699-8902, Hzy8902@126.com
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200
Lei Chen, MD, +86-189-3017-2789, andrewch@263.net
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200
Liping Sun, MD, +86-186-1621-7981, sunlipings@126.com
- Recruiting
Shanghai Jiading District Central Hospital
Shanghai, Shanghai Municipality, 201
Bojun Dong, MD, +86-137-6121-0771, dongbaijun@renji.com
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361
Guangcheng Luo, MD, +86-137-9927-1972, lgch@xmu.edu.cn
- Recruiting
Zhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, 363
Xiao Yang, MD, +86-135-2226-2196, yangxiaol@pumch.cn
About this study
Official title: Prospective, Multicentre, Single-Arm Clinical Trial on the Safety and Effectiveness of Transperineal Irreversible Electroporation for the Ablation of Benign Prostatic Hyperplasia
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:
Read more
- How many participants have improved urine flow 3 months after treatment?
- How do urinary symptoms, quality of life, and prostate size change after treatment?
- 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Composite steep-pulse therapeutic device (CNP-III)
- Keywords
- steep pulse ablation, Irreversible electroporation, Lower urinary tract symptoms, Transrectal ultrasound-guided, Minimally invasive surgical treatment
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite steep-pulse therapeutic device (CNP-III)Device
Also called steep pulse therapy system, 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.
| Study group | Role | What they receive |
|---|---|---|
| Irreversible electroporation | Experimental | Transrectal ultrasound-guided transperineal irreversible electroporation using the composite steep-pulse therapeutic device (CNP-III; Zhejiang CuraWay Medical Technology Co., Ltd., Hangzhou, China). Receives: Device: Composite steep-pulse therapeutic device (CNP-III) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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
Measured: baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start11 Sep 2024
- Primary completion29 May 2027 (estimated)
- Study completion29 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Tian'an Jiang, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867315
- Sponsor's protocol ID
- steeppulse-prostate
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No