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

Recruiting N/A Interventional Study
Benign Prostatic Hyperplasia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
45 – 80
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
Medtecx Co Ltd. · Industry
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About This Trial
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 g…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. * Post-urination residual urine …
Contacts

Jim Zhang, MD

jim.zhang@medtecx.com

jim.zhang@medtecx.com

CONTACT