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

NCT02683980 | Completed Results

• 1 other identifier: LUM-SBU-VP-15-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Ablation Time

  Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.

  Intraprocedural (procedure time is typically 1 to 3 hours)

• Ablation Rate

  Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes

  Baseline and 3-month follow-up visit

• Efficiency of the Laser to Ablate the Prostate

  Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J

  Baseline and 3-month follow-up visit

• Safety: Intraoperative Complications

  Number and type of intraoperative complications

  Intraoperative (procedure time is typically 1 to 3 hours)

• Safety: Perioperative Complications

  Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia

  Post-procedure through 3 months

Secondary Outcomes (10)

• Erectile Dysfunction

  Baseline and 3-month follow-up visit

• Visibility During Procedure

  Intraprocedural (procedure time is typically 1 to 3 hours)

• Number of Fibers Used During Procedure

  Intraprocedural (procedure time is typically 1 to 3 hours)

• Catheterization Time

  Postoperatively through study completion up to 3 months

• Hospital Stay Duration

  Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months)

Study Arms (1)

Ablation of the prostate

EXPERIMENTAL

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

Device: Lumenis Pulse P120H and Xpeeda side firing fiber

Interventions

Lumenis Pulse P120H and Xpeeda side firing fiber DEVICE

Ablation of the prostate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Lumenis Be Ltd.: collaborator

Study Sites (1)

New York Methodist Hospital

New York, New York, 11215, United States

Location

Results Point of Contact

• Title: Clinical Program Manager
• Organization: Boston Scientific

teri.bird@bsci.com

612-322-1189

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 17, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Locations

US (1)