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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The purpose of this observational study is to evaluate the prostatic arterial embolization (PAE) with Embozene® Microspheres (Boston Scientific) in sphere sizes of 250 µm for the treatment of symptomatic benign prostatic hyperplasia (BPH).
EmboProstate is an observational study that collects data of patients with benign prostatic hyperplasia that are treated with 250 µm Embozene ® Microspheres (Boston Scientific). The study evaluates the efficacy and safety of the microspheres for prostatic arterial embolization for benign prostata hyperplasia treatment. 10 adult male subjects will be enrolled in this study. If eligible patients are recruited, they will undergo the prostate artery embolization procedure in our radiology department. Once the catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected embospheres will slow the blood flow to the prostate reducing urinary tract symptoms caused by BPH. Within one week after PAE as well as after one, three and six months post-procedure an MRI examination ill occur. A follow-up visit using a questionnaire is due after 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embozene | Patients receiving Embozene microspheres |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embozene Microspheres | Drug | Intraarterial application |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic improvement of BPH symptoms (= International Prostate Symptom Score (IPSS) < 18 and reduction > 25% QoL (Quality of Life) < 4 & reduction ≥ & / or Qmax > 15 ml/s & increase of Qmax ≥ 3,0ml/s) at 6 and 12 months post intervention | Improvement of feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia | Baseline, follow-up after 1 months, 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) | The number and the severity of adverse events will be recorded to evaluate the safety of prostate artery embolization. Events will be reported by subjects within the 1st week after PAE and at follow-up after 6 months. | Within 1st week after PAE and follow-up after 1 months, 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Qmax (reduction of postvoid residual volume) | Measure of urine flow rate. Q max = max flow rate | Follow-up after 6 months |
| Reduction of prostate volume determined by volumetric measurement (MRI / transrectal Ultrasound) |
Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic (within clinical routine)
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Teichgräber, Prof. | Institute of Diagnostic and Interventional Radiology | Study Director |
| Marc-Oliver Grimm, Prof. | Department of Urology | Study Chair |
| Tobias Franiel, Dr. med. | Institute of Diagnostic and Interventional Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, University Hospital Jena | Jena | Thuringia | 07740 | Germany |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Measuring the percentage of prostate tissue devascularized, based on contrast-enhanced MRI by estimating the prostate volume and the estimated portion that is non-perfused on MRI.
| Follow up MRI examinations: within the first week after PAE, 1, 3 and 6 months after PAE |
| D052801 |
| Male Urogenital Diseases |