Actively Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Led by Chinese PLA General Hospital · Updated on 2025-12-05
30
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 to 85 years
- International Prostate Symptom Score (IPSS) of 8 or higher indicating moderate to severe lower urinary tract symptoms
- Poor response to or refusal of pharmacological treatment
- Prostate volume between 30 and 80 mL
- Maximum urinary flow rate (Qmax) less than 15 mL/s
- Post-void residual urine volume less than 300 mL
- Willingness to provide informed consent and participate in postoperative follow-up
You will not qualify if you...
- Prostate volume less than 30 mL or greater than 80 mL
- Severe urinary tract infection
- Preoperative diagnosis of prostate cancer
- Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction
- Presence of prostatitis
- History of invasive prostate interventions such as radiofrequency ablation, laser therapy, or microwave treatment
- Severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders making surgery unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
Q
Qing Yuan, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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