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

NCT02683980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-25

Study results available
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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

DEVICE

Lumenis Pulse P120H and Xpeeda side firing fiber

Sponsors & Collaborators

  • Lumenis Be Ltd.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02683980 on ClinicalTrials.gov