NCT06817733

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: Male
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-12-20
• Completion: 2025-12-31
• First posted: 2025-02-10
• Last updated: 2025-12-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study