NCT04267445

Evaluate the Safety and Effectiveness of Using Echogenic Embolic Agent for Embolization of Prostate Artery for Treatment of Men With BPH (PAE CEUS)

A Prospective Single Centre Study to Evaluate the Safety and Effectiveness of Using Contrast Enhanced Ultrasound and Echogenic Embolic Agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

A prospective single centre study to evaluate the safety and effectiveness of using contrast enhanced ultrasound and echogenic embolic agent Ekobi Embolization Microspheres in Prostate Artery Embolization for the Treatment of Men with Benign Prostatic Hyperplasia

Detailed description

Single center, open label, pilot study. After screening and baseline testing, eligible patients will undergo transarterial embolization of the prostatic vasculature. Each patient will undergo a single embolization procedure. After completion of treatment in the first 2 patients and a review of follow-up assessments after 7 days, subsequent patients will be enrolled if no safety concerns have arisen in the first 2 patients. Patients will be enrolled until 15 patients have undergone treatment. The patients will undergo MRI, contrast enhanced ultrasound and computerized tomography (CT) angiograpy/intra-procedural cone beam CT as required. Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization. Magnetic resonance imaging (MRI) and CEUS is used to assess changes in prostate volume and in central gland enhancement characteristics using 3D volume assessment software.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Embolization of prostatic artery under ultrasound guidance	Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-12-01
• Completion: 2023-03-01
• First posted: 2020-02-12
• Last updated: 2020-02-17