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To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)

Clinical Trial Summary

A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study

Clinical Trial Description

This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population. The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04823221
Study type Observational
Source Boston Scientific Corporation
Contact
Status Completed
Phase
Start date July 10, 2021
Completion date August 1, 2021
View Details
See also
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