Clinical trial NCT02683980: Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
Official title: Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Treatment of Benign Prostatic Hyperplasia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Lumenis Be Ltd.
First posted: 2016-02-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ablation time
timeFrame: change from the beginning of the procedure to the end of the procedure.
measure: Ablation rate
timeFrame: change from baseline prostate volume at 3 month follow up
measure: efficiency of the laser to ablate the prostate
timeFrame: change from baseline prostate volume at 3 month follow up
Secondary outcomes:
measure: Clavien scaled Complications
timeFrame: during the procedure, 48 hours post procedure, 1 month and 3 month following the procedure.
measure: Intraoperative complications
timeFrame: during the procedure
measure: the need for blood transfusion
timeFrame: during the procedure as compared to baseline.
measure: Urinary test
timeFrame: Baseline, up to 24 hours post procedure, 3 month post procedure
measure: Erectile Dysfunction
timeFrame: 3 month following the procedure as compared to baseline
measure: Readmission for secondary operation
timeFrame: up to 3 month post procedure
measure: American Urological Association score
timeFrame: Baseline,1 month, 3 month
measure: Blood analysis
timeFrame: Baseline , 1 month , 3 month
measure: urinary function
timeFrame: Baseline , 1 month , 3 month
measure: hemoglobin test
timeFrame: Baseline ,immediately following the procedure
measure: hematocrit test
timeFrame: Baseline ,immediately following the procedure
measure: International Prostate Symptom Score Quality of Life subjective questionnaire
timeFrame: Baseline,1 month , 3 month
measure: urinary function
timeFrame: Baseline , 1 month , 3 month
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
References: