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

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)

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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