Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging

NCT06817733 · tracked via the Priya Life Science China tracker

Sponsor

Chinese PLA General Hospital

Phase

Not applicable

Started

2025-04-15

Last updated

2026-08-11

Condition(s) studied

Benign Prostatic Hyperplasia (BPH)

Investigational drug(s) / intervention(s)

Transurethral Thermal Vaporization of the ProstateRezūm Water Vapor Thermal Therapy System

Transurethral Thermal Vaporization of the Prostate: After anesthesia, the patient is placed in the lithotomy position, and standard aseptic preparation and draping are performed. A cystoscope and a transrectal ultrasound (TRUS) probe are inserted. Following real-time image fusion and localization according to the preoperative plan, needles are inserted to deliver thermal vaporization to the prostate. Each needle treatment lasts 8 seconds, and the entire procedure is completed within 200 seconds after activation of the needle pathway.

Rezūm Water Vapor Thermal Therapy System: The Rezūm System is an FDA-cleared and NMPA-approved transurethral water vapor thermal therapy device for the treatment of benign prostatic hyperplasia (BPH). The system delivers thermal energy in the form of water vapor to ablate hyperplastic prostate tissue. The treatment is performed under cystoscopic and transrectal ultrasound (TRUS) guidance with electromagnetic navigation.

Study summary

Objective of the Clinical Trial

The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are:

Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests.

Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance.

Postoperative Follow-up:

Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire.

Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR).

Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.

Eligibility

Sex

MALE

Min age

45 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * Age 45-85 years; * International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life; * Poor response to pharmacological treatment or refusal of pharmacological treatment; * Prostate volume 30-80 mL; * Maximum urinary flow rate (Qmax) \< 15 mL/s; * Post-void residual urine volume (PVR) \< 300 mL; * Willingness to provide informed consent and participate in postoperative follow-up. Exclusion Criteria: * Prostate volume \< 30 mL or \> 80 mL; * Severe urinary tract infection; * Preoperative definitive diagnosis of prostate cancer; * Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction; * Patients with prostatitis; * History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment; * Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.

Primary outcome measure(s)

Volume changes in the prostate transition zone — From enrollment to 6 months after surgery
The volume of the transitional zone measured by MRI before and 6 months after surgery

Trial sites (1)

Facility	City	Region	Status
Chinese PLA General Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06817733 on ClinicalTrials.gov ↗ ← All trials in China