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IP received FDA clearance for use in PAE as treatment for BPH.
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The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.
The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embosphere Microspheres | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS) | The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Prostate Size, as Determined by MRI | Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6. | Baseline and 12 months |
| Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing |
| Measure | Description | Time Frame |
|---|---|---|
| Total PAE Procedure Time | Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery. | Study treatment hospitalization (expected to be less than 1 day) |
| Total Fluoroscopy Time for PAE |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rush, MD | South Florida Medical Imaging, Holy Cross Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
The study involved a screening period during which patient eligibility was determined. There were no screen failures.
Following FDA and IRB approval for the study, recruitment began and the first subject was enrolled for the study on September 24, 2015. Enrollment was closed on June 29, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Patients will receive prostate artery embolization (PAE) with Embosphere Microspheres. Embosphere Microspheres |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Prostate artery embolization (PAE) with Embosphere Microspheres. Embosphere Microspheres |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS) | The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome. | Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up). | Posted | Number | units on a scale | 12 months |
|
Adverse events (AEs) occurring during the clinical trial and the protocol-defined 12-month follow-up period were recorded.
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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 | Treatment | This is a single arm study. All subjects with eligibility confirmed during the screening period and completing Visit 1 (Prostate Artery Embolization) within 4 weeks of screening are included in the arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site burning | General disorders | MedDRA version 18.1 | Systematic Assessment |
Enrollment was limited due to early study termination. This was a result of Embosphere Microspheres (investigational product for this IDE) receiving FDA clearance for embolization of prostatic arteries for symptomatic benign prostatic hyperplasia.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Toot ARNP | South Florida Medical Imaging | 954-267-6626 | cynthia.toot@holy-cross.com |
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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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Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy. |
| 12 Months |
| Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing | Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes. | 12 Months |
| Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing | Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment. | 12 Months |
| Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF) | The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome. | 12 Months |
| Change From Baseline in Serum Prostate Specific Antigen (PSA) | Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels. | Baseline and12 Months |
| Prostate Artery Embolization (PSA) Related Adverse Events | Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported. | 12 Months |
| Overall Adverse Events | All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome | 12 Months |
Parameter to be measured during PAE procedure, for informational purposes. |
| Study treatment hospitalization (expected to be less than 1 day) |
| Type of Contrast Media Delivered for PAE | Parameter to be measured during PAE procedure, for informational purposes | Study treatment hospitalization (expected to be less than 1 day) |
| Volume of Contrast Delivered for PAE | Parameter to be measured during PAE procedure, for informational purposes | Study treatment hospitalization (expected to be less than 1 day) |
| Volume of Embolic Delivered for PAE | Parameter to be measured during PAE procedure, for informational purposes | Study treatment hospitalization (expected to be less than 1 day) |
| Number of Origins of Prostatic Blood Supply | Parameter to be measured during PAE procedure, for informational purposes | Study treatment hospitalization (expected to be less than 1 day) |
| Duration of Hospitalization Post PAE | Parameter to be measured during PAE procedure, for informational purposes | Study treatment hospitalization (expected to be less than 1 day) |
| Duration of [Urinary] Catheterization Post PAE | Parameter to be measured during PAE procedure, for informational purposes | Study treatment hospitalization (expected to be less than 1 day) |
| Participants |
|
| Age, Continuous | Mean | Full Range | 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 | Number | participants |
|
| Use of 5 alpha reductase inhibitors | Count of Participants | Participants |
|
| Use of alpha adrenergic blockers | Count of Participants | Participants |
|
| Use of other medications or supplements [to treat BPH] | Count of Participants | Participants |
|
| Use of other BPH treatments | Count of Participants | Participants |
|
This is a single arm study. This arm includes all subjects with study eligibility confirmed during the screening period and Visit 1 (Prostate Artery Embolization) completed within 4 weeks of eligibility confirmation.
|
|
|
| Secondary | Change From Baseline in Prostate Size, as Determined by MRI | Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6. | Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up). | Posted | Number | grams | Baseline and 12 months |
|
|
|
|
| Secondary | Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing | Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy. | The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Qmax was not obtained. This was reported as a protocol deviation in the study. | Posted | 12 Months |
|
|
|
| Secondary | Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing | Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes. | The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the PVR was not obtained. This was reported as a protocol deviation in the study. | Posted | 12 Months |
|
|
|
| Secondary | Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing | Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment. | The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Pdet was not obtained. This was reported as a protocol deviation in the study. | Posted | 12 Months |
|
|
|
| Secondary | Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF) | The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome. | Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up). | Posted | Number | units on scale | 12 Months |
|
|
|
|
| Secondary | Change From Baseline in Serum Prostate Specific Antigen (PSA) | Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels. | Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up). | Posted | Number | ng/mL | Baseline and12 Months |
|
|
|
|
| Secondary | Prostate Artery Embolization (PSA) Related Adverse Events | Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported. | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Count of Units | occurrence | 12 Months | occurrence | occurrence |
|
|
|
|
| Secondary | Overall Adverse Events | All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Number | occurrence | 12 Months |
|
|
|
|
| Other Pre-specified | Total PAE Procedure Time | Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery. | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Mean | Full Range | minutes | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Total Fluoroscopy Time for PAE | Parameter to be measured during PAE procedure, for informational purposes. | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Mean | Full Range | minutes | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Type of Contrast Media Delivered for PAE | Parameter to be measured during PAE procedure, for informational purposes | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Count of Participants | Participants | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Volume of Contrast Delivered for PAE | Parameter to be measured during PAE procedure, for informational purposes | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Mean | Full Range | milliliter | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Volume of Embolic Delivered for PAE | Parameter to be measured during PAE procedure, for informational purposes | Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE). | Posted | Mean | Full Range | milliliter | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Number of Origins of Prostatic Blood Supply | Parameter to be measured during PAE procedure, for informational purposes | Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE). | Posted | Mean | Full Range | number of vessels | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Duration of Hospitalization Post PAE | Parameter to be measured during PAE procedure, for informational purposes | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Mean | Full Range | minutes | Study treatment hospitalization (expected to be less than 1 day) |
|
|
|
|
| Other Pre-specified | Duration of [Urinary] Catheterization Post PAE | Parameter to be measured during PAE procedure, for informational purposes | Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted. | Posted | Mean | Full Range | minutes | Study treatment hospitalization (expected to be less than 1 day) |
|
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|
|
| 1 |
| 2 |
| 1 |
| 2 |
| 1 |
| 2 |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Bladder irritation | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Systematic Assessment |
|
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| D052801 |
| Male Urogenital Diseases |
| Pollakiuria |
|
| Bladder irritation |
|
| Title | Measurements |
|---|---|
|
| Pollakiuria |
|
| Bladder irritation |
|
| Nasopharyngitis |
|
| Urinary tract infection |
|
| Acute myocardial infarction |
|
| Acute sinusitis |
|
| Allergic rhinitis |
|
|