Safety and Efficacy of OCL 503 in Prostate Artery Embolization

NCT02509975 | Completed

• 1 other identifier: OCL503-P2-PAE-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy

Keywords

embolization; prostate

Outcome Measures

Primary Outcomes (2)

• Safety of OCL 503 as measured by Adverse Events reporting.

  Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.

  12 months

• International Prostate Symptom Score (IPSS)

  Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.

  12 months

Secondary Outcomes (3)

• Tissue Response

  12 months

• Uroflowmetry

  12 months

• International Index of Erectile Function (IIEF)

  12 months

Study Arms (1)

Prostate Artery Embolization

EXPERIMENTAL

Transarterial administration of OCL 503 to the arteries feeding the prostate.

Device: Prostate artery embolization.

Interventions

Prostate artery embolization. DEVICE

Embolization of the prostatic vasculature with OCL 503 using a microcatheter.

Prostate Artery Embolization

Eligibility Criteria

• Age: 51 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
• Patient is greater than 50 years of age
• Patient has had a pelvic examination within the past 6 months
• Patient has been refractory to medical therapy for the last 6 months, or has refused medical therapy
• Patient has a Qmax below 15 mL/s or acute urinary retention
• Prostate is larger than 40 cubic centimetres
• Patient is willing and able to provide written, informed consent

You may not qualify if:

• Known malignancy
• Serum PSA \> 10 ng/mL at screening
• Advanced atherosclerosis and tortuosity of the iliac arteries
• Prior transurethral resection of the prostate (TURP)
• Post void retention (PVR) \> 250 mL
• Chronic use of metronidizole
• Phytotherapy for BPH within last two weeks of screening visit
• Secondary renal insufficiency due to prostatic obstruction
• Chronic renal failure (GSR \< 60)
• Large bladder diverticula or bladder stones
• Claustrophobia or other contraindications related to performing MRI
• Compromised hematopoietic function
• Anaphylactic reaction to drug or anesthetic, allergic reaction to iodine or contrast media
• Investigational drug or experimental therapy in the past 4 weeks
• Abnormal coagulation profile

Sponsors & Collaborators

• IMBiotechnologies Ltd.: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Richard Owen, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 28, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

CA (1)