Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683980
Recruitment Status : Unknown
Verified January 2017 by Lumenis Ltd..
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Lumenis Ltd.

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.


Condition or disease Intervention/treatment Phase
Treatment of Benign Prostatic Hyperplasia Device: Lumenis Pulse P120H and Xpeeda side firing fiber Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
Study Start Date : February 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ablation of the prostate
ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser
Device: Lumenis Pulse P120H and Xpeeda side firing fiber



Primary Outcome Measures :
  1. Ablation time [ Time Frame: 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.

  2. Ablation rate [ Time Frame: 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.

  3. efficiency of the laser to ablate the prostate [ Time Frame: 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.


Secondary Outcome Measures :
  1. Clavien scaled Complications [ Time Frame: 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.


  2. Intraoperative complications [ Time Frame: 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.

  3. the need for blood transfusion [ Time Frame: during the procedure as compared to baseline. ]
    the need for blood transfusion as an indication of blood loss .

  4. Urinary test [ Time Frame: 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.

  5. Erectile Dysfunction [ Time Frame: 3 month following the procedure as compared to baseline ]
    Erectile Dysfunction test using international score.

  6. Readmission for secondary operation [ Time Frame: 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.

  7. American Urological Association score [ Time Frame: 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 .

  8. Blood analysis [ Time Frame: Baseline , 1 month , 3 month ]
    PSA blood test is evaluated to asses the efficiency of the procedure.

  9. urinary function [ Time Frame: Baseline , 1 month , 3 month ]
    PVR [ml] functional test is evaluated to asses the efficiency of the procedure.

  10. hemoglobin test [ Time Frame: Baseline ,immediately following the procedure ]
    pre and post-operative hemoglobin blood test as an indication of blood loss.

  11. hematocrit test [ Time Frame: Baseline ,immediately following the procedure ]
    hematocrit blood test as an indication of blood loss.

  12. International Prostate Symptom Score Quality of Life subjective questionnaire [ Time Frame: Baseline,1 month , 3 month ]
    questionnaire that asses the effect of symptoms on everyday life and their interference with daily activities.

  13. urinary function [ Time Frame: Baseline , 1 month , 3 month ]
    QMax [mL/s] is evaluated to asses the efficiency of the procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683980


Locations
Layout table for location information
United States, New York
New York Methodist Hospital
New York, New York, United States, 11215
Sponsors and Collaborators
Lumenis Ltd.
Layout table for additonal information
Responsible Party: Lumenis Ltd.
ClinicalTrials.gov Identifier: NCT02683980    
Other Study ID Numbers: LUM-SBU-VP-15-02
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases