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Laser Ablation

FLA for BPH Active Treatment for Benign Prostatic Hyperplasia

N/A
Waitlist Available
Research Sponsored by Prostate Laser Center, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous until completion of the study at 2 years
Awards & highlights

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.

Eligible Conditions
  • Benign Prostatic Hyperplasia
  • Urinary Frequency/Urgency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous until completion of the study at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous until completion of the study at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BPH Impact Index Change
International Prostate Symptom Score (IPSS) Change
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: FLA for BPH Active TreatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI Guided Transrectal Periuretheral Transitional Zone Ablation
2017
N/A
~10

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
607 Previous Clinical Trials
828,665 Total Patients Enrolled
Prostate Laser Center, PLLCLead Sponsor
Medtronic, Inc., a Minnesota, U.S.A. companyUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
2017. "MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03131544.
~1 spots leftby May 2025
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