Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
MALE
NCT06725212

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

Led by Medtecx Co Ltd. · Updated on 2024-12-17

126

Participants Needed

10

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 45 to 80 years with symptoms from benign prostatic hyperplasia needing invasive treatment
  • International Prostate Symptom Score (IPSS) of 13 points or higher
  • Maximum urinary flow rate no greater than 15 ml/s with minimum urine volume of 125 ml
  • Post-urination residual urine volume of 250 ml or less
  • Prostate volume between 30 and 80 cm³ measured by MRI
  • Willing to voluntarily participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Presence of malignant tumors in the urinary system or other advanced cancers
  • Difficulty inserting instruments due to urethral narrowing or bladder neck contracture
  • Severe blood clotting disorders
  • Urinary incontinence caused by weak sphincter or severe urge incontinence
  • Severe cardiovascular diseases including advanced heart block, ischemic heart disease, or heart failure (NYHA grade II or higher)
  • Prostate biopsy within 2 months before joining
  • Recent unstable angina, heart attack, stroke, or transient ischemic attack within 6 months
  • Prior invasive prostate treatments like radiofrequency ablation, balloon dilation, microwave therapy, laser treatments, electroreception, prostate stents, or suspension procedures
  • History of rectal surgery (except hemorrhoidectomy) or rectal diseases affecting treatment or evaluation
  • Uncontrolled acute infections of urinary or reproductive systems
  • Neurological diseases affecting bladder or sphincter function
  • Presence of bladder stones
  • Inability to undergo MRI examination
  • Currently participating in other clinical trials or recent participation in drug or device trials within specified timeframes
  • Other conditions deemed unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 10 locations

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022

Actively Recruiting

2

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China, 101100

Actively Recruiting

3

BeiJing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China, 102218

Actively Recruiting

4

PLA General Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

5

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

Wuhan, Hubei, China, 430030

Actively Recruiting

6

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210003

Actively Recruiting

7

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330038

Actively Recruiting

8

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

Actively Recruiting

9

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China, 200080

Actively Recruiting

10

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China, 300211

Actively Recruiting

Loading map...

Research Team

J

Jim Zhang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here