NCT02683980

Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure. The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.

Conditions

• Treatment of Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Lumenis Pulse P120H and Xpeeda side firing fiber

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-02-17
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

1 site across 1 country: United States