NCT06817733 Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
| NCT ID | NCT06817733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese PLA General Hospital |
| Condition | Benign Prostatic Hyperplasia (BPH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06817733 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 85 Years, studying Benign Prostatic Hyperplasia (BPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817733 currently recruiting?
Yes, NCT06817733 is actively recruiting participants. Contact the research team at qyuanmd@outlook.com for enrollment information.
Where is the NCT06817733 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06817733 clinical trial?
NCT06817733 is sponsored by Chinese PLA General Hospital. The trial plans to enroll 30 participants.