Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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.
- 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.
- the need for blood transfusion [during the procedure as compared to baseline.]
the need for blood transfusion as an indication of blood loss .
- 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.
- 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.
- urinary function [Baseline , 1 month , 3 month]
PVR [ml] functional 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.
- urinary function [Baseline , 1 month , 3 month]
QMax [mL/s] is evaluated to asses the efficiency of the procedure.
Eligibility Criteria
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
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Documented or suspected prostate cancer and / or bladder cancer
-
Neurogenic bladder disorder / neurogenic voiding dysfunction
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Urethral strictures
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York Methodist Hospital | New York | New York | United States | 11215 |
Sponsors and Collaborators
- Lumenis Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LUM-SBU-VP-15-02