Treatment of Benign Prostatic Hyperplasia Clinical Trial
Official title:
Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
| Verified date | January 2017 |
| Source | Lumenis Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 20 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York Methodist Hospital | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Lumenis Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ablation time | Calculating the lasing time to ablate the prostate as an indication for treatment efficiency. | change from the beginning of the procedure to the end of the procedure. | |
| Primary | Ablation rate | 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. | change from baseline prostate volume at 3 month follow up | |
| Primary | efficiency of the laser to ablate the prostate | Ablation efficacy calculated as: Prostate volume measured using baseline and post treatment (3 month) TRUS / energy invested during the procedure. | change from baseline prostate volume at 3 month follow up | |
| Secondary | Clavien scaled Complications | 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. |
during the procedure, 48 hours post procedure, 1 month and 3 month following the procedure. | |
| Secondary | Intraoperative complications | to evaluate laser operation malfunction including Capsule perforation or Conversion to TURP (Transurethral Resection of the Prostate) to maintain hemostasis or complete the procedure. | during the procedure | |
| Secondary | the need for blood transfusion | the need for blood transfusion as an indication of blood loss . | during the procedure as compared to baseline. | |
| Secondary | Urinary test | analyzing known complication urinary system related including: Urinary Retention ,Hematuria, Dysuria ,Infection,Urge incontinence,Stress incontinence. | Baseline, up to 24 hours post procedure, 3 month post procedure | |
| Secondary | Erectile Dysfunction | Erectile Dysfunction test using international score. | 3 month following the procedure as compared to baseline | |
| Secondary | Readmission for secondary operation | to evaluate the need for additional intervention based on blood and urine tests and subjective questionnaires, as an indicator of procedure efficiency. | up to 3 month post procedure | |
| Secondary | American Urological Association score | 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 . | Baseline,1 month, 3 month | |
| Secondary | Blood analysis | PSA blood test is evaluated to asses the efficiency of the procedure. | Baseline , 1 month , 3 month | |
| Secondary | urinary function | PVR [ml] functional test is evaluated to asses the efficiency of the procedure. | Baseline , 1 month , 3 month | |
| Secondary | hemoglobin test | pre and post-operative hemoglobin blood test as an indication of blood loss. | Baseline ,immediately following the procedure | |
| Secondary | hematocrit test | hematocrit blood test as an indication of blood loss. | Baseline ,immediately following the procedure | |
| Secondary | International Prostate Symptom Score Quality of Life subjective questionnaire | questionnaire that asses the effect of symptoms on everyday life and their interference with daily activities. | Baseline,1 month , 3 month | |
| Secondary | urinary function | QMax [mL/s] is evaluated to asses the efficiency of the procedure. | Baseline , 1 month , 3 month |