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

Boston Scientific

Status: Completed

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 BPH (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 > 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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