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

NCT03131544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-25

Study results available
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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.

Conditions

  • BPH
  • Prostate Hyperplasia
  • Urinary Frequency/Urgency

Interventions

DEVICE

MRI Guided Transrectal Periuretheral Transitional Zone Ablation

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Prostate Laser Center, PLLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2018-10-15
Completion
2020-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131544 on ClinicalTrials.gov