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Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia
Sponsor: Medtecx Co Ltd.
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.
Official title: 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
Key Details
Gender
MALE
Age Range
45 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2024-03-26
Completion Date
2026-06-01
Last Updated
2024-12-17
Healthy Volunteers
No
Conditions
Interventions
Water Vapor Thermal Ablation
The water vapor thermal ablation system injects thermal energy in the form of water vapor into the hyperplastic prostate tissue in controlled doses. The injected water vapor quickly disperses through the gaps between tissue cells. When water vapor comes into contact with tissue, it cools and condenses immediately. The stored heat energy is released, denaturing the cell membrane, causing cell death and eventually being absorbed or shed by the body and excreted through urination, thus improving the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
Cystoscopy
Cystoscopy is a procedure that allows the doctor to examine the lining of patient's bladder and the tube that carries urine out of the body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into the bladder.
Locations (10)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
BeiJing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
PLA General Hospital
Beijing, Beijing Municipality, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China