Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 .
- 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.
- Erectile Dysfunction [ Time Frame: 3 month following the procedure as compared to baseline ]Erectile Dysfunction test using international score.
- 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.
- 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 .
- Blood analysis [ Time Frame: Baseline , 1 month , 3 month ]PSA blood test is evaluated to asses the efficiency of the procedure.
- urinary function [ Time Frame: Baseline , 1 month , 3 month ]PVR [ml] functional test is evaluated to asses the efficiency of the procedure.
- hemoglobin test [ Time Frame: Baseline ,immediately following the procedure ]pre and post-operative hemoglobin blood test as an indication of blood loss.
- hematocrit test [ Time Frame: Baseline ,immediately following the procedure ]hematocrit blood test as an indication of blood loss.
- 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.
- urinary function [ Time Frame: Baseline , 1 month , 3 month ]QMax [mL/s] is evaluated to asses the efficiency of the procedure.
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
|United States, New York|
|New York Methodist Hospital|
|New York, New York, United States, 11215|