Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
- Conditions
- Treatment of Benign Prostatic Hyperplasia
- Interventions
- Device: Lumenis Pulse P120H and Xpeeda side firing fiber
- Registration Number
- NCT02683980
- Lead Sponsor
- Boston Scientific Corporation
- 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 PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with recommended settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ablation of the prostate Lumenis Pulse P120H and Xpeeda side firing fiber ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser
- Primary Outcome Measures
Name Time Method efficiency of the laser to ablate the prostate change from baseline prostate volume at 3 month follow up Ablation efficacy calculated as: Prostate volume measured using baseline and post treatment (3 month) TRUS / energy invested during the procedure.
Ablation time change from the beginning of the procedure to the end of the procedure. Calculating the lasing time to ablate the prostate as an indication for treatment efficiency.
Ablation rate change from baseline prostate volume at 3 month follow up Ablation rate calculated as: Prostate volume measured using baseline and 3 months post treatment TRUS (Trans Rectal Ultrasound) / procedure time as an indication for treatment efficiency.
- Secondary Outcome Measures
Name Time Method Intraoperative complications during the procedure to evaluate laser operation malfunction including Capsule perforation or Conversion to TURP (Transurethral Resection of the Prostate) to maintain hemostasis or complete the procedure.
Urinary test Baseline, up to 24 hours post procedure, 3 month post procedure analyzing known complication urinary system related including: Urinary Retention ,Hematuria, Dysuria ,Infection,Urge incontinence,Stress incontinence.
Erectile Dysfunction 3 month following the procedure as compared to baseline Erectile Dysfunction test using international score.
Readmission for secondary operation up to 3 month post procedure to evaluate the need for additional intervention based on blood and urine tests and subjective questionnaires, as an indicator of procedure efficiency.
the need for blood transfusion during the procedure as compared to baseline. the need for blood transfusion as an indication of blood loss .
Clavien scaled Complications during the procedure, 48 hours post procedure, 1 month and 3 month following the procedure. Complications will be evaluated according to Clavien scale.
Modified Clavien Grading:
Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5.urinary function Baseline , 1 month , 3 month QMax \[mL/s\] is evaluated to asses the efficiency of the procedure.
American Urological Association score Baseline,1 month, 3 month questionnaires that helps categorize urinary symptoms and asses the effect of symptoms on everyday life and their interference with daily activities as an indication of procedure efficiency .
Blood analysis Baseline , 1 month , 3 month PSA blood test is evaluated to asses the efficiency of the procedure.
hemoglobin test Baseline ,immediately following the procedure pre and post-operative hemoglobin blood test as an indication of blood loss.
hematocrit test Baseline ,immediately following the procedure hematocrit blood test as an indication of blood loss.
International Prostate Symptom Score Quality of Life subjective questionnaire Baseline,1 month , 3 month questionnaire that asses the effect of symptoms on everyday life and their interference with daily activities.
Trial Locations
- Locations (1)
New York Methodist Hospital
🇺🇸New York, New York, United States
New York Methodist Hospital🇺🇸New York, New York, United States