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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- IMBiotechnologies Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety of OCL 503 as measured by Adverse Events reporting.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Safety of OCL 503 as measured by Adverse Events reporting.
Time Frame: 12 months
Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.
International Prostate Symptom Score (IPSS)
Time Frame: 12 months
Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
Secondary Outcomes
- International Index of Erectile Function (IIEF)(12 months)
- Uroflowmetry(12 months)
- Tissue Response(12 months)