NCT03055624

Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Male
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Investigator-initiated study to evaluate the safety and efficacy of prostate artery embolization for the treatment lower urinary tract symptoms in patients with benign prostatic hyperplasia

Detailed description

This is a phase I/II, single center, prospective, single arm, investigational study to evaluate the safety and efficacy of prostate artery embolization (PAE) for treatment of severe lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) in patients that have either failed or are intolerant to medical management. Once eligibility is confirmed, patients will undergo PAE with Embosphere Microspheres. Embolization will consist of a minimally invasive angiogram and treatment of the prostate arteries with the Embosphere particles to reduce blood flow to the prostate. Following treatment, patients will return for follow-up visits at 1, 6, 12, and 24 months post PAE.

Conditions

• Prostatic Hyperplasia, Benign
• Enlarged Prostate With Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	Embosphere microparticles for prostate artery embolization	Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2017-02-16
• Last updated: 2020-03-31
• Results posted: 2020-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study