A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Water Vapor Thermal Ablation System for the Treatment of Benign Prostatic Hyperplasia
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate the efficacy and safety of the Water Vapor Thermal Therapy system for the treatment of Benign Prostatic Hyperplasia under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related (serious) adverse events. The primary effectiveness endpoint will be changes (treatment group vs control group) from baseline in International Prostate Symptom Score (IPSS) 3 months after medical device intervention.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:
• Men aged 45-80 years (inclusive) with symptoms secondary to BPH and requiring invasive intervention.
• International Prostate Symptom Score (IPSS) ≥13 points.
• Maximum urinary flow rate (Qmax): ≤15 ml/s, with a minimum urine volume of ≥125 ml.
• Voluntarily participate in the clinical trial and sign the informed consent form.
Locations
Other Locations
China
Beijing Luhe Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
BeiJing Tsinghua Changgung Hospital
RECRUITING
Beijing
PLA General Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Shanghai First People's Hospital
RECRUITING
Shanghai
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Jim Zhang, MD
jim.zhang@medtecx.com
jim.zhang@medtecx.com
Time Frame
Start Date:2024-03-26
Estimated Completion Date:2026-06-01
Participants
Target number of participants:126
Treatments
Active_comparator: Treatment group
Subjects with BPH with LUTS will be randomized into the treatment group to receive the Water Vapor Thermal treatment via cystoscope.
Sham_comparator: Sham control group
Subjects with BPH with LUTS will be randomized into the control group to receive a cystoscopy as the sham treatment.~Crossover treatment: 3 months after the sham treatment, qualified subjects in the control group can choose to receive the crossover Water Vapor Thermal treatment via cystoscope.