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

NCT ID: NCT02683980

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablation of the prostate

ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser

Group Type: EXPERIMENTAL

Lumenis Pulse P120H and Xpeeda side firing fiber

Intervention Type: DEVICE

Interventions

Lumenis Pulse P120H and Xpeeda side firing fiber

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject will be older than 18 years of age
• Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
• Subject is a candidate for surgery treatment
• Subject is willing and has signed the Informed Consent Form
• AUA score ≥ 12
• Qmax <15 mL/s

Exclusion Criteria

• Need to perform concomitant procedure, other than prostate vaporization
• PVR > 300 mL
• Current Urine retention and Pdet <40 cm H20
• Documented or suspected prostate cancer and / or bladder cancer
• Neurogenic bladder disorder / neurogenic voiding dysfunction
• Urethral strictures
• Previous prostatic, bladder neck, or urethral surgery
• Known history of spinal cord injury
• Urogenital trauma
• Bladder neck stricture
• Evidence of urinary tract infection
• History of chronic prostatitis

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New York Methodist Hospital

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LUM-SBU-VP-15-02

Identifier Type: -

Identifier Source: org_study_id