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

Primary Purpose

Treatment of Benign Prostatic Hyperplasia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumenis Pulse P120H and Xpeeda side firing fiber
Sponsored by
Lumenis Be Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Benign Prostatic Hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • New York Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablation of the prostate

Arm Description

ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser

Outcomes

Primary Outcome Measures

Ablation time
Calculating the lasing time to ablate the prostate as an indication for treatment efficiency.
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.
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.

Secondary Outcome Measures

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.
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.
the need for blood transfusion
the need for blood transfusion as an indication of blood loss .
Urinary test
analyzing known complication urinary system related including: Urinary Retention ,Hematuria, Dysuria ,Infection,Urge incontinence,Stress incontinence.
Erectile Dysfunction
Erectile Dysfunction test using international score.
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.
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 .
Blood analysis
PSA blood test is evaluated to asses the efficiency of the procedure.
urinary function
PVR [ml] functional test is evaluated to asses the efficiency of the procedure.
hemoglobin test
pre and post-operative hemoglobin blood test as an indication of blood loss.
hematocrit test
hematocrit blood test as an indication of blood loss.
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.
urinary function
QMax [mL/s] is evaluated to asses the efficiency of the procedure.

Full Information

First Posted
January 31, 2016
Last Updated
August 28, 2017
Sponsor
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02683980
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation of the prostate
Arm Type
Experimental
Arm Description
ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser
Intervention Type
Device
Intervention Name(s)
Lumenis Pulse P120H and Xpeeda side firing fiber
Primary Outcome Measure Information:
Title
Ablation time
Description
Calculating the lasing time to ablate the prostate as an indication for treatment efficiency.
Time Frame
change from the beginning of the procedure to the end of the procedure.
Title
Ablation rate
Description
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.
Time Frame
change from baseline prostate volume at 3 month follow up
Title
efficiency of the laser to ablate the prostate
Description
Ablation efficacy calculated as: Prostate volume measured using baseline and post treatment (3 month) TRUS / energy invested during the procedure.
Time Frame
change from baseline prostate volume at 3 month follow up
Secondary Outcome Measure Information:
Title
Clavien scaled Complications
Description
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.
Time Frame
during the procedure, 48 hours post procedure, 1 month and 3 month following the procedure.
Title
Intraoperative complications
Description
to evaluate laser operation malfunction including Capsule perforation or Conversion to TURP (Transurethral Resection of the Prostate) to maintain hemostasis or complete the procedure.
Time Frame
during the procedure
Title
the need for blood transfusion
Description
the need for blood transfusion as an indication of blood loss .
Time Frame
during the procedure as compared to baseline.
Title
Urinary test
Description
analyzing known complication urinary system related including: Urinary Retention ,Hematuria, Dysuria ,Infection,Urge incontinence,Stress incontinence.
Time Frame
Baseline, up to 24 hours post procedure, 3 month post procedure
Title
Erectile Dysfunction
Description
Erectile Dysfunction test using international score.
Time Frame
3 month following the procedure as compared to baseline
Title
Readmission for secondary operation
Description
to evaluate the need for additional intervention based on blood and urine tests and subjective questionnaires, as an indicator of procedure efficiency.
Time Frame
up to 3 month post procedure
Title
American Urological Association score
Description
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 .
Time Frame
Baseline,1 month, 3 month
Title
Blood analysis
Description
PSA blood test is evaluated to asses the efficiency of the procedure.
Time Frame
Baseline , 1 month , 3 month
Title
urinary function
Description
PVR [ml] functional test is evaluated to asses the efficiency of the procedure.
Time Frame
Baseline , 1 month , 3 month
Title
hemoglobin test
Description
pre and post-operative hemoglobin blood test as an indication of blood loss.
Time Frame
Baseline ,immediately following the procedure
Title
hematocrit test
Description
hematocrit blood test as an indication of blood loss.
Time Frame
Baseline ,immediately following the procedure
Title
International Prostate Symptom Score Quality of Life subjective questionnaire
Description
questionnaire that asses the effect of symptoms on everyday life and their interference with daily activities.
Time Frame
Baseline,1 month , 3 month
Title
urinary function
Description
QMax [mL/s] is evaluated to asses the efficiency of the procedure.
Time Frame
Baseline , 1 month , 3 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
New York Methodist Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

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

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