CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Lumenis Pulse P120H and Xpeeda side firing fiberdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02683980
NCT02683980N/ACompleted

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

Boston Scientific Corporation·interventional·Posted Feb 17, 2016·Updated Nov 25, 2025

In Brief

A clinical study evaluating Lumenis Pulse P120H and Xpeeda side firing fiber for Treatment of Benign Prostatic Hyperplasia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsLumenis Be Ltd.

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 17, 2016
Enrollment StartFeb 1, 2016
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.4 years ago

Interventions

Lumenis Pulse P120H and Xpeeda side firing fiberdevice