Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

NCT ID: NCT04563221

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-01

Brief Summary

This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Balloon occlusion microcatheter

Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter.

Group Type: EXPERIMENTAL

Prostatic artery embolization

Intervention Type: DEVICE

Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.

Standard microcatheter

Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.

Group Type: EXPERIMENTAL

Prostatic artery embolization

Intervention Type: DEVICE

Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.

Interventions

Prostatic artery embolization

Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 45 years and ≤ 85 years old
• Prostate volume ≥ 40 mL and ≤ 300 mL
• Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
• Refractory or intolerant to medical management
• Ineligibility for or refusal of surgical management
• No evidence of prostate cancer

Exclusion Criteria

• History of pelvic cancer
• Neurogenic bladder disorder
• Bladder diverticula greater than 5 cm or bladder stones
• Acute urinary retention with Foley catheter dependence
• Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
• Prior surgical prostate intervention
• Active participation in another clinical trial

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Andrew Picel

OTHER

Sponsor Role: lead

Responsible Party

Andrew Picel

Assistant Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew Picel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

51982

Identifier Type: -

Identifier Source: org_study_id