Status:
ACTIVE_NOT_RECRUITING
Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA
Lead Sponsor:
Urological Research Network, LLC
Conditions:
Male Urogenital Diseases
Genital Diseases, Male
Eligibility:
MALE
40-85 years
Phase:
PHASE1
Brief Summary
This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse e...
Detailed Description
INTRODUCTION The Echolaser system (ELS - Elesta SpA. 50041, Calenzano (FI), Italy ), which consists of Echolaser X4 plus Echolaser Smart Interface is a new device for minimal invasive procedures. The...
Eligibility Criteria
Inclusion
- Presence of Lower Urinary Tract Symptoms (LUTS) measure by International Prostate Symptom Scores (IPSS) greater than 9
- Serum creatinine levels \<1.5 ng/dl and GFR \> 55
- Peak urinary flow rate (Qmax): ≥ 5 mL/sec to ≤ 15 mL/sec, with a minimum voided volume of ≥ 125 mL, measured with uroflowmetry, pressure flow studies or urodynamic investigation
- Post-void residual (PVR): ≤ 250 mL
- Prostate volume: ≥ 30 and ≤ 120 cc, measured by transrectal ultrasound
- Signed informed consent
Exclusion
- Previous invasive prostate intervention (TURP, laser, ablation, etc.)
- History of prostate or bladder cancer
- Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
- Evidence of neurogenic bladder
- Indwelling Foley catheter or clean intermittent catheterization (CIC) in the prior 30 days
- Inability or unwillingness to tolerate temporary discontinuation of anticoagulation or anti-platelet therapy
- Other conditions / status listed in full protocol
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04760483
Start Date
November 20 2020
End Date
March 20 2026
Last Update
January 26 2023
Active Locations (1)
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1
Urology Specialist Group
Hialeah, Florida, United States, 33016