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PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)

Clinical Trial Summary

This post-marketing study is being conducted to evaluate the long-term safety and effectiveness of the Prolieve Thermodilatation® System (Prolieve®) in the treatment of Benign Prostatic Hyperplasia (BPH). A secondary objective is to assess the safety and effectiveness of re-treatment with Prolieve® and determine the percent of subjects electing to be re-treated with Prolieve® rather than alternate therapy. This study will follow subjects treated with Prolieve® at 2 weeks, 3 months, and on a yearly basis for 5 years after treatment. Both efficacy and safety information will be collected at all follow-up visits. Procedural and safety information will be collected during treatment to further substantiate the findings of the pivotal trial.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00407953
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 2005
Completion date December 2018
View Details
See also
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