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| Name | Class |
|---|---|
| BTG International Inc. | OTHER |
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Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.
Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | Patients will receive the Prostatic Artery Embolization procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostatic Artery Embolization | Device | LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in IPSS Score | The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35). | Baseline and 6 months following PAE procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Quality of Life Scores | The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5. | Baseline and 6 months following PAE procedure |
| Mean Change in Urine Flow |
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Inclusion Criteria
Exclusion Criteria
Gender is based on the anatomical gender assigned at birth. Patients must have a prostate in order to enroll in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Ari Isaacson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals | Chapel Hill | North Carolina | 27599 | United States | ||
| Vascular Institute of Virginia |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in IPSS Score | The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35). | This group includes all subjects that received the PAE procedure with 6 month follow up IPSS data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months following PAE procedure |
|
1 year following PAE procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients will receive the Prostatic Artery Embolization procedure. Prostatic Artery Embolization: LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| brief penile pain and sensitivity | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Clinical Research Operations, Department of Radiology | University of North Carolina at Chapel Hill | 919-966-4997 | rad_research@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2019 | Jan 12, 2021 | Prot_SAP_000.pdf |
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This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
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Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second. |
| Baseline and 6 months following PAE Procedure |
| Mean Change in Prostate Volume | Change in the prostate volume measured in grams. | Baseline and 3 months following |
| Percent of Prostate Infarcted | Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume. | 6 months following PAE procedure |
| Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure | Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation. | 3 months following PAE procedure |
| Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure | Number of participants that experience minor complications following the PAE procedure. | Up to 12 months following PAE procedure |
| Mean Change in IIEF Score | Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function. | Baseline and 6 months following PAE procedure |
| Woodbridge |
| Virginia |
| 22193 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| IPSS | The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35). | Mean | Standard Deviation | units on a scale |
|
| IIEF | The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life | The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5. | Mean | Standard Deviation | units on a scale |
|
| Urine Flow (mL/s) | Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second. | 3 participants never underwent baseline urodynamic testing because they withdrew from the study. | Mean | Standard Deviation | mL/s |
|
|
|
| Secondary | Mean Change in Quality of Life Scores | The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5. | This group includes all patients that received the PAE procedure and had 6 month QoL data collected. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months following PAE procedure |
|
|
|
| Secondary | Mean Change in Urine Flow | Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second. | Patients with 6-month urodynamic testing | Posted | Mean | Standard Deviation | mL/s | Baseline and 6 months following PAE Procedure |
|
|
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| Secondary | Mean Change in Prostate Volume | Change in the prostate volume measured in grams. | All participants receiving the PAE procedure with imaging following the procedure. | Posted | Mean | Standard Deviation | grams | Baseline and 3 months following |
|
|
|
| Secondary | Percent of Prostate Infarcted | Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume. | Unable to collect infarction data because the CT scans did not show it effectively. | Posted | 6 months following PAE procedure |
|
|
| Secondary | Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure | Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation. | All patients that received the PAE procedure. | Posted | Count of Participants | Participants | 3 months following PAE procedure |
|
|
|
| Secondary | Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure | Number of participants that experience minor complications following the PAE procedure. | All patients that received the PAE procedure. | Posted | Count of Participants | Participants | Up to 12 months following PAE procedure |
|
|
|
| Secondary | Mean Change in IIEF Score | Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function. | All patients that received the PAE procedure and had 6 month follow up data for IIEF | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months following PAE procedure |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
| brief rectalgia or anal pain | Renal and urinary disorders | Non-systematic Assessment |
|
| dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| increased frequency | Renal and urinary disorders | Non-systematic Assessment |
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| penile ulceration | Renal and urinary disorders | Non-systematic Assessment |
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| temporary increased urgency to urinate | Renal and urinary disorders | Non-systematic Assessment |
|
| temporary hematuria | Renal and urinary disorders | Non-systematic Assessment |
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| temporary urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
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