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

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Boston Scientific

Status

Terminated

Conditions

Treatment of Benign Prostatic Hyperplasia

Treatments

Device: Lumenis Pulse P120H and Xpeeda side firing fiber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02683980
LUM-SBU-VP-15-02

Details and patient eligibility

About

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 PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with recommended settings.

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 > 300mL
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Ablation of the prostate
Experimental group
Description:
ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser
Treatment:
Device: Lumenis Pulse P120H and Xpeeda side firing fiber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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