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RECRUITING
NCT06725212
NA

Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia

Sponsor: Medtecx Co Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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).

DEVICE

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