NCT02021032

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Medifocus, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").

Conditions

• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
DEVICE	Prolieve	Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.

Timeline

• Start date: 2006-02-01
• Primary completion: 2018-02-01
• Completion: 2018-08-01
• First posted: 2013-12-27
• Last updated: 2015-09-24

Locations

8 sites across 1 country: United States