NCT02509975

Safety and Efficacy of OCL 503 in Prostate Artery Embolization

An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: IMBiotechnologies Ltd. · Industry
• Sex: Male
• Age: 51 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.

Detailed description

Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, IPSS, uroflowmetry, IIEF, and MRI pelvic imaging. Following conventional catheter angiography with cone-beam CT to confirm catheter placement and prostatic vasculature, each patient will undergo transarterial embolization with OCL 503. OCL 503 will be administered intra-arterially via microcatheter until there is stasis of blood flow. Patient assessments include blood work, IPSS, uroflowmetry, IIEF, MRI and patient interviews conducted at 3 months, 6 months, and 12 months post embolization.

Conditions

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy

Interventions

Type	Name	Description
DEVICE	Prostate artery embolization.	Embolization of the prostatic vasculature with OCL 503 using a microcatheter.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-07-28
• Last updated: 2018-08-08

Locations

1 site across 1 country: Canada