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| Name | Class |
|---|---|
| Siemens Medical Solutions | INDUSTRY |
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The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embozene Microspheres | Experimental | Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embozene Microspheres | Device | Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax (peak urinary flow rate) assessment | 12 months |
| Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures | 2 weeks | |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax assessment | 24 months |
| Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures | 24 months | |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | IPSS (International Prostate Symptom Score) | 12 months |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | IPSS | 24 months |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QoL(quality of life question) | 12 months |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QoL | 24 months |
| Clinical improvement in Lower Urinary Tract Symptoms (LUTS) |
| Measure | Description | Time Frame |
|---|---|---|
| Urine flow rate as measured by QMax | 1 month | |
| Urine flow rate as measured by QMax | 24 months | |
| Post-void residual measured in ml/cc |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Feazell, BS | Contact | 434-297-5682 | JF9RF@virginia.edu | |
| Brigitte J Kelly, BSN RN CCRC | Contact | 434-297-7136 | bjk3c@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ziv J Haskal, MD | Professor of Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health Systems | Recruiting | Charlottesville | Virginia | 22908 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 13, 2024 | |
| Reset | Jun 10, 2024 |
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QMax |
| 24 months |
| 1 month |
| Post-void residual measured in ml/cc | 24 months |
| UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score | 1 month |
| UCLA-PCI-SF score | 24 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 13, 2024 | Jun 10, 2024 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D053448 | Prostatism |
| D059411 | Lower Urinary Tract Symptoms |
| D006965 | Hyperplasia |
| D052801 | Male Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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