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NCT03131544 · ClinicalTrials.gov registry record · NA
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
A NA study of BPH and Prostate Hyperplasia, sponsored by Prostate Laser Center, P.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03131544: Completed NA study of BPH and Prostate Hyperplasia, sponsored by Prostate Laser Center, P.
NCT03131544 is a NA study of BPH and Prostate Hyperplasia that has completed, run by Prostate Laser Center, P. The registered enrollment target is 10 participants, below the 68-participant average among 5 other BPH trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131544, a NA study of BPH and Prostate Hyperplasia, has completed, sponsored by Prostate Laser Center, P.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
Conditions Studied
Interventions
- DEVICE MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Study Locations (1)
Texas
- Prostate Laser Center, PLLC - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-04-17 |
| Est. Completion | 2020-05-15 |
| Phase | NA |
What the finished NCT03131544 record still lists
NCT03131544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 68-participant average among 5 other BPH trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with BPH appearing as the primary indexed condition, and to 1 intervention - of which MRI Guided Transrectal Periuretheral Transitional Zone Ablation is the first listed.
NCT03131544 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03131544 about?
NCT03131544 is a clinical study titled "MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)". 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)....
What is the current status of trial NCT03131544?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-04-17. Estimated completion is 2020-05-15.
What conditions does trial NCT03131544 study?
This clinical trial studies the following conditions: BPH, Prostate Hyperplasia, Urinary Frequency/Urgency.
What interventions are being tested in trial NCT03131544?
The interventions under investigation include: MRI Guided Transrectal Periuretheral Transitional Zone Ablation (DEVICE).
Who is sponsoring clinical trial NCT03131544?
This trial is sponsored by Prostate Laser Center, P, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03131544 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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