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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003446-33 | EudraCT Number |
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510(K) Approval Gained for Product
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The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).
The study will consist of a screening period in which patient eligibility will be determined and baseline assessments performed. Once eligibility is confirmed, patients will be enrolled within 4 weeks of baseline imaging to receive either TURP or PAE with Embosphere Microspheres. After treatment, patients will return for follow-up visits at Months 1, 3, 6, and 12. At each of these visits patients will complete IPSS and IIEF questionnaires and have a physical exam, laboratory assessments (including PSA), a DRE, and a transrectal ultrasound of the prostate. At each visit patients will have a cystoscopy and proctoscopy if medically indicated. Cystoscopy is necessary in all cases of hematuria (injury associated with bleeding). Proctoscopy is necessary in all cases of bleeding per the rectum. An MRI of the prostate will be conducted at the 3 and 12 month visits. Uroflowmetry testing will be performed at the 1 and 12 month visits, and at other visits if medically indicated. MRIs will be assessed by blinded Central Reviewers.
The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post treatment. Patients will continue to be followed annually for up to 4 additional years. At a minimum, patients will be requested to complete the IPSS and International Index of Erectile Dysfunction (IIEF) questionnaires by telephone, email or mail once per year during this long term follow up period. Patients who are willing to return to the clinic will have a physical exam, MRI of the prostate, digital rectal exam (DRE), transrectal ultrasound of the prostate, PSA, and uroflowmetry testing performed each year. Treatments for LUTS due to BPH after the study treatment and 12 month follow up are complete will be documented during the long term follow up period to the extent possible. This long term follow up data will be summarized and submitted separately from the data for the initial 12 months of this study.
Safety will be evaluated throughout the initial 12 months of the study by assessing adverse events, as well as changes in laboratory values, and findings on physical examination. Concomitant medication usage will be assessed. A follow up ECG will be performed at the 12 month visit.
Patient recruitment is anticipated to take approximately 2 years. Duration of each patient's participation is expected to be 5 years, including a 4 year long term follow up period. The total duration of the study will be approximately 7 years, including long term follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate artery embolization (PAE) | Experimental | Prostate artery embolization using Embosphere Microspheres |
|
| Transurethral resection of the prostate (TURP) | Active Comparator | Transurethral Resection of the Prostate (TURP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embosphere Microspheres | Device |
| ||
| TURP |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) - Total Score at 12 Months | The International Prostate Symptom Score (I-PSS) 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). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization Post Procedure | The duration of hospitalization associated with the procedure will be calculated in hours. T | 1 month |
| Duration of Post Procedure Catheterization | The duration of post procedure catheterization will be calculated in hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Free Prostate Specific Antigen (PSA) at 6 Month Follow up | Free PSA percentage summarized for both groups at 6 months follow up | 6 month follow up |
| Peak Urine Flow Rate (Qmax) at 1 Month | The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments was assessed at 1 month follow up. (Additional timepoints were not assessed due to early termination). |
Inclusion Criteria:
Patient is age 50 to 79, inclusive
Patient has signed informed consent
Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study treatment
Patient has a baseline IPSS Score > 13 at baseline
Patient has a prostate size of at least 50 grams and not more than 90 grams, measured by MRI
Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused
Patient must be a candidate for TURP
Patient must meet one of the following criteria:
Exclusion Criteria:
Active urinary tract infection
Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous cell skin cancer
The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND has not been on the same drug dosage for 6 months with a stable voiding pattern
• Dosage of these medications should not change during study participation unless medically necessary
Patient has taken antidepressants, anticholinergics, androgens or gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of study treatment AND has not been on the same drug dosage for at least 3 months with a stable voiding pattern
Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug (NSAID) or anti-platelet therapy for 7 days prior to study treatment
Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint, etc)
Patient has an asymmetric prostate, with > 20% difference in size between lobes
Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months
Baseline serum creatinine level > 1.8 mg/dl
Known upper tract renal disease
Cystolithiasis or chronic hematuria within 3 months prior to study treatment
Active prostatitis
Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
History of pelvic irradiation or radical pelvic surgery
Patient is interested in future fertility
Coagulation disturbances not normalized by medical treatment
Acute urinary retention requiring an indwelling catheter
Known major iliac arterial occlusive disease
Allergy to iodinated contrast agents
Hypersensitivity to gelatin products
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| Name | Affiliation | Role |
|---|---|---|
| Francisco, Cesar Carnevale, PhD | University of Sao Paolo, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach VA | Long Beach | California | 90822 | United States | ||
| VA Greater Los Angeles Healthcare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prostate Artery Emoblization (PAE) | Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres |
| FG001 | Transurethral Resection of the Prostate (TURP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 15, 2021 |
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|
|
| 1 month |
| Number of Adverse Events Per Patient | Adverse events during the study were predominantly mild. There are over 4 times as many PAE patients as TURP, so the overall incidence rate of events is proportional to the size of the cohort represented. The most common events among patients who underwent embolization were transient dysuria, bladder spasm, hematuria, hematospermia, nausea and fever. The last 2 are typical of post embolic syndrome common to all embolization procedures. The most frequent adverse events for surgery patients were dysuria and hematuria. Events also include non-TEAEs. | Through early termination of study (with less than 25% of subjects completing 12 month follow up) |
| Number of Patients With Procedure Related Adverse Events | Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the case report form (CRF) which began prior to treatment will not be included in the summary tables but will be included in the AE data listings. | TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up |
| 1 month follow-up |
| International Index of Erectile Function (IIEF) | Erectile Function (Questions 1-5 & 15), score range 0-5, max score = 30 Orgasmic Function (Questions 9-10), score range 0-5, max score = 10 Sexual Desire (Questions 11-12), score range 1-5, max score = 10 Intercourse Satisfaction (Questions 6-8), score range 0-5, max score = 15 Overall Satisfaction (Questions 13-14), score range 1-5, max score = 10 SCORING for erectile dysfunction (Total of Q1-5 and Q15) is interpreted as follows: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction For all subscales, higher scores = less dysfunction/dissatisfaction Total IIEF is out of 75 | 6 months |
| Mean Prostate Volume, as Determined by MRI | The mean prostate volume as assessed by MRI is summarized at 3 month time point. | 3 month follow-up |
| Post-void Residual Urinary Volume (PVR) | The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments is summarized for both treatment groups at 1 month time point. | 1 month follow-up |
| Total Prostate Specific Antigen (PSA) at 6 Months | Prostate specific antigen (PSA) will be summarized for both treatment groups for 6 month time point | 6 months |
| Los Angeles |
| California |
| 90073 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Miami VA Healthcare System | Miami | Florida | 33125 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21207 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
Transurethral Resection of the Prostate (TURP)
TURP
| COMPLETED |
|
| NOT COMPLETED |
|
Clinical trial results analyzed when study was ongoing and at time of De Novo submission. Trial was terminated when De Novo clearance was obtained. No further analysis was performed and IDE was terminated. Baseline characteristics are presented for all enrolled subjects at time of study termination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prostate Artery Emoblization (PAE) | Prostate artery embolization using Embosphere Microspheres Embosphere Microspheres |
| BG001 | Transurethral Resection of the Prostate (TURP) | Transurethral Resection of the Prostate (TURP) TURP |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| International Prostate Symptom Score (IPSS) | The International Prostate Symptom Score (I-PSS) 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). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Peak Urine Flow Rate (Qmax reported as mL/s) | Deviation recorded for Qmax not performed on 1 subject at baseline | Mean | Standard Deviation | mL/s |
| ||||||||||||||
| Post Void Residual (PVR) | Mean | Standard Deviation | mL |
| |||||||||||||||
| Detrusor Pressure (Pdet) (mmH2O) | Protocol deviations recorded for Pdet not captured on 2 patients. | Mean | Standard Deviation | mmH2O |
| ||||||||||||||
| International Index of Erectile Function (IIEF) - Total | Q1-5 refer to erectile function. Q6-8 refer to satisfaction with intercourse. Q9-10 refer to orgasmic function. Q11-12 ask about sexual desire. Q13-14 refer to overall sexual satisfaction. Q15 refers to erectile function. Q1-5 &15 range from 0-5 (max score 30). Q 9-10 range from 0-5 (max score 10). Q11-12 range from 1-5 (max score 10). Q6-8 range from 0-5 (max score 15). Q13-14 range from 1-5 (max score 10). Erectile function score (Q1-5 & 15): 1-10=severe, 11-16=moderate, 17-21=mild-moderate, 22-25=mild, 26-30=no dysfunction. Total IIEF out of 75 pts, higher scores = less dysfunction | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Prostate volume (g) | Mean | Standard Deviation | g |
| |||||||||||||||
| Prostate Specific Antigen (PSA) (ng/mL) | Mean | Standard Deviation | ng/mL |
| |||||||||||||||
| Free Prostate Specific Antigen (PSA) | Free PSA was not collected at baseline on all subjects due to protocol deviation | Mean | Standard Deviation | percentage of Free PSA |
|
| 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 | International Prostate Symptom Score (IPSS) - Total Score at 12 Months | The International Prostate Symptom Score (I-PSS) 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). Mild is generally less than or equal to 7, moderate is 8-19 and severe is 20-35. Total score was measured at 12 months. | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | total score on a scale | 12 months |
|
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| ||||||||||||||||||||||||||||
| Secondary | Duration of Hospitalization Post Procedure | The duration of hospitalization associated with the procedure will be calculated in hours. T | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | hours | 1 month |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Post Procedure Catheterization | The duration of post procedure catheterization will be calculated in hours. | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | hours | 1 month |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Adverse Events Per Patient | Adverse events during the study were predominantly mild. There are over 4 times as many PAE patients as TURP, so the overall incidence rate of events is proportional to the size of the cohort represented. The most common events among patients who underwent embolization were transient dysuria, bladder spasm, hematuria, hematospermia, nausea and fever. The last 2 are typical of post embolic syndrome common to all embolization procedures. The most frequent adverse events for surgery patients were dysuria and hematuria. Events also include non-TEAEs. | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Number | events per patient | Through early termination of study (with less than 25% of subjects completing 12 month follow up) |
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| Secondary | Number of Patients With Procedure Related Adverse Events | Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the case report form (CRF) which began prior to treatment will not be included in the summary tables but will be included in the AE data listings. | De Novo classification from FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization for symptomatic benign prostatic hyperplasia received 2017. IDE supplement proposed the termination of study follow-up visits; FDA granted approval of termination 03Nov2017. Early termination resulted in small numbers analyzed w less than 25% reaching 12 month follow-up. | Posted | Count of Participants | Participants | TEAEs at time of study termination, with less than 25% of subjects completing 12 month follow up |
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| Other Pre-specified | Free Prostate Specific Antigen (PSA) at 6 Month Follow up | Free PSA percentage summarized for both groups at 6 months follow up | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | percentage | 6 month follow up |
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| Other Pre-specified | Peak Urine Flow Rate (Qmax) at 1 Month | The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments was assessed at 1 month follow up. (Additional timepoints were not assessed due to early termination). | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | mL/s | 1 month follow-up |
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| Other Pre-specified | International Index of Erectile Function (IIEF) | Erectile Function (Questions 1-5 & 15), score range 0-5, max score = 30 Orgasmic Function (Questions 9-10), score range 0-5, max score = 10 Sexual Desire (Questions 11-12), score range 1-5, max score = 10 Intercourse Satisfaction (Questions 6-8), score range 0-5, max score = 15 Overall Satisfaction (Questions 13-14), score range 1-5, max score = 10 SCORING for erectile dysfunction (Total of Q1-5 and Q15) is interpreted as follows: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction For all subscales, higher scores = less dysfunction/dissatisfaction Total IIEF is out of 75 | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Prostate Volume, as Determined by MRI | The mean prostate volume as assessed by MRI is summarized at 3 month time point. | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | grams | 3 month follow-up |
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| |||||||||||||||||||||||||||||
| Other Pre-specified | Post-void Residual Urinary Volume (PVR) | The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments is summarized for both treatment groups at 1 month time point. | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | mL | 1 month follow-up |
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| Other Pre-specified | Total Prostate Specific Antigen (PSA) at 6 Months | Prostate specific antigen (PSA) will be summarized for both treatment groups for 6 month time point | Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects. | Posted | Mean | Standard Deviation | ng/mL | 6 months |
|
|
Study was intended to follow subjects through 12 months, but was terminated early due to de novo 510k clearance. Less than 25% of subjects reached the 12 month time point.
Denominator for % calculations is 52 subjects in the PAE arm and 6 subjects in the TURP arm. Subjects randomized & never treated are not included.
If a subject had multiple reports of same AE type, he is only counted once for that AE. System organ class counts = number of subjects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prostate Artery Embolization (PAE) Arm | Denominator for percent calculations is 52 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE. | 0 | 52 | 6 | 52 | 40 | 52 |
| EG001 | Transurethral Resection of the Prostate (TURP) Arm | Denominator for percent calculations is 6 treated subjects. Subjects who were randomized and never treated are not included. If a subject had multiple reports of the same type of AE, he is only counted once for that AE. | 0 | 6 | 1 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impacted stool | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Catheter site inflammation | General disorders | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Bladder injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| Bladder discomfort | Renal and urinary disorders | Systematic Assessment |
| ||
| Ejaculation disorder | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Hydrocele | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Hypogonadism | Endocrine disorders | Systematic Assessment |
| ||
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal rigidity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anorectal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dental necrosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faecaloma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiatal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Catheter site related reaction | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Facial pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Local swelling | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Suprapubic pain | General disorders | Systematic Assessment |
| ||
| Cellulits | Infections and infestations | Systematic Assessment |
| ||
| Localised infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood urine present | Investigations | Systematic Assessment |
| ||
| Urine leukocyte esterase positive | Investigations | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Chest wall mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Sciatica | Nervous system disorders | Systematic Assessment |
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| Sensory loss | Nervous system disorders | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Incontinence | Renal and urinary disorders | Systematic Assessment |
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| Micturition | Renal and urinary disorders | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
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| Terminal dribbling | Renal and urinary disorders | Systematic Assessment |
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| Urethral pain | Renal and urinary disorders | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Urinary straining | Renal and urinary disorders | Systematic Assessment |
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| Epididymal cyst | Reproductive system and breast disorders | Systematic Assessment |
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| Haematospermia | Reproductive system and breast disorders | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
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| Penile burning sensation | Reproductive system and breast disorders | Systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | Systematic Assessment |
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| Perineal pain | Reproductive system and breast disorders | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | Systematic Assessment |
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| Retrograde ejaculation | Reproductive system and breast disorders | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | Systematic Assessment |
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| Varicocele | Reproductive system and breast disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arthroscopic surgery | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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Merit Medical received 513(f)(2) (de novo) classification from the FDA expanding the indication for Embosphere Microspheres to include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) in 2017. An IDE supplement was submitted for this study proposing the termination of study follow-up visits. The FDA granted approval of termination on 03 Nov 2017. Early termination resulted in small numbers analyzed, incomplete enrollment and follow-up of study subjects.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Casey Holland | Merit Medical | 1 (617) 842-0251 | casey.holland@merit.com |
| May 17, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
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| Erectile function sub-score |
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| Orgasmic function sub-score |
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| Sexual desire sub-score |
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| Intercourse satisfaction sub-score |
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| Overall satisfaction sub-score |
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| OG001 | Transurethral Resection of Prostate (TURP) | Summary of treatment emergent adverse events presented as number of events in the TURP arm. Denominator for percent calculations is 6 treated subjects. Subjects who were randomized and never treated are not included. An AE is considered related to treatment if the Investigator assessment of relationship to study treatment was possible, probably, or definite. If a subject had multiple reports of the same type of AE, he is only counted once for that AE. System organ class counts are number of subjects. |
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Transurethral Resection of the Prostate (TURP)
TURP
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