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Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate) — REZUM  

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)

Clinical Trial Summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Clinical Trial Description

This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01912339
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date July 2013
Completion date October 17, 2016
View Details
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