CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
MRI Guided Transrectal Periuretheral Transitional Zone Ablationdevice
Likely dose
Not stated in record
Key inclusion· 5
  • Diagnosis of lower urinary tract symptoms (LUTS)
  • Prostate volume 40–200 cc
  • Age ≥45 years
  • IPSS score ≥15
Key exclusion· 14
  • History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of prostate cancer
  • Need for catheterization to relieve obstruction
  • Daily use of incontinence materials or padding
  • Neurogenic or hypotonic bladder, Parkinson's Disease, or uncontrolled diabetes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03131544
NCT03131544N/ACompleted

MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

Prostate Laser Center, PLLC·interventional·Posted Apr 27, 2017·Updated Apr 25, 2024

In Brief

A clinical study evaluating MRI Guided Transrectal Periuretheral Transitional Zone Ablation for BPH and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartApr 17, 2017
Primary CompletionOct 15, 2018
Study CompletionMay 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.2 years ago

Interventions

MRI Guided Transrectal Periuretheral Transitional Zone Ablationdevice

Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.