Safety and Efficacy of OCL 503 in Prostate Artery Embolization

IMBiotechnologies

Status

Completed

Conditions

Benign Prostatic Hypertrophy

Benign Prostatic Hyperplasia

Treatments

Device: Prostate artery embolization.

Study type

Interventional

Funder types

Industry

Identifiers

NCT02509975

OCL503-P2-PAE-01

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

Male

Ages

51+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Allergy to bovine collagen