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

NARecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

March 26, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2026

Conditions
Benign Prostatic Hyperplasia
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.

Trial Locations (10)

101100

RECRUITING

Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing

102218

RECRUITING

BeiJing Tsinghua Changgung Hospital, Beijing

200080

RECRUITING

Shanghai First People's Hospital, Shanghai

210003

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

230022

RECRUITING

The First Affiliated Hospital of Anhui Medical University, Hefei

300211

RECRUITING

The Second Hospital of Tianjin Medical University, Tianjin

330038

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

430030

RECRUITING

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

710061

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

Unknown

RECRUITING

PLA General Hospital, Beijing

All Listed Sponsors
lead

Medtecx Co Ltd.

INDUSTRY