NCT03131544

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Prostate Laser Center, PLLC · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	MRI Guided Transrectal Periuretheral Transitional Zone Ablation	Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.

Timeline

• Start date: 2017-04-17
• Primary completion: 2018-10-15
• Completion: 2020-05-15
• First posted: 2017-04-27
• Last updated: 2024-04-25
• Results posted: 2024-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study