Benign Prostatic Hyperplasia Clinical Trial
Official title:
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
Verified date | August 2018 |
Source | IMBiotechnologies Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 51 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
IMBiotechnologies Ltd. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | International Prostate Symptom Score (IPSS) | Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503. | 12 months | |
Secondary | Tissue Response | Measurement in the change in size of the prostate by MRI at 12 months post embolization of the prostatic vasculature with OCL 503. | 12 months | |
Secondary | Uroflowmetry | Measurement of Qmax, post-voiding bladder retention (PVR) at 12 months post embolization of the prostatic vasculature with OCL 503. | 12 months | |
Secondary | International Index of Erectile Function (IIEF) | Measurement of IIEF by questionnaire at 12 months post embolization of the prostatic vasculature using OCL 503. | 12 months |
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