- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03527589
Embosphere® PROstate Post Market Study (PROstate)
A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75015
- Hôspital Européan Georges Pompidou HEGP
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Cuneo, Italy, 12100
- Azienda Ospedaliera S. Croce e Carle Cuneo
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Milano, Italy, 20162
- Ospedale Niguarda Ca' Granda
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Bournemouth, United Kingdom, BH7 7DW
- Royal Bournemouth and Christchurch Hospital
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Reading, United Kingdom
- Royal Berkshire Hospital
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Oxford
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Headington, Oxford, United Kingdom, OX3 7LE
- Churchill Hospital
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Surrey
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Camberley, Surrey, United Kingdom, GU16 7UJ
- Frimley Park Hospital
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California
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Long Beach, California, United States, 90822
- VA Long Beach Healthcare Systems
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Los Angeles, California, United States, 90095
- University of California Los Angeles
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Los Angeles, California, United States, 90095
- Ronald Reagan UCLA Medical Center
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Orange, California, United States, 92868
- UC Irvine Health
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
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Miami, Florida, United States, 33136
- University of Miami- Miller School of Medicine
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Missouri
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Saint Louis, Missouri, United States, 63110
- St. Louis University Hospital
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Washington
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Spokane, Washington, United States, 99204
- Providence Sacred Heart
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient has signed informed consent
- Patient age is 18 years or older at time of informed consent
- Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
Exclusion Criteria:
- Patient is unable or unwilling to provide follow-up information
- Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
- Any other reason the investigator deems cause for exclusion
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Treated with Embosphere Microspheres
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion).
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Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).
Time Frame: 12 Months
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The two time points used in the calculation were baseline and 12 months.
The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints).
From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes.
There are a total of 7 questions on the scale and the scores from each question are summed to get a total score.
A negative change score means improvement of outcomes.
'Scores on a scale' is the unite of measure
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12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.
Time Frame: 3, 24 Months
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The time points used in the calculation were baseline, 3 months and 24 months.
The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints).
The same calculation was also done at 24 months.
From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes.
There are a total of 7 questions on the scale and the scores from each question are summed to get a total score.
A negative change score means improvement of outcomes.
'Scores' on a scale is the unite of measure.
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3, 24 Months
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Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.
Time Frame: 3, 24 Months
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The time points used in the calculation were baseline, 3 months and 24 months.
The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints).
The same calculation was also done at 24 months.
From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes.
There are a total of 7 questions on the scale and the scores from each question are summed to get a total score.
A negative change score means improvement of outcomes.
'Scores' on a scale is the unite of measure.
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3, 24 Months
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Device or Procedure Related Adverse Events Post Procedure.
Time Frame: 3, 12, 24 Months
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The measure used to assess "device or procedure related adverse events post procedure" at three different time points (3, 12, 24 months) are frequencies and percentages. For each visit (or reporting time point), the event rate will be calculated as the number of subjects with certain event terms over the number of evaluable subjects. The evaluable subjects at each reporting time point include all subjects who are enrolled and
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3, 12, 24 Months
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Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
Time Frame: 3, 12, 24 Months
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3, 12, 24 Months
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Technical Success Defined as Successful Embolization of the Treated Prostate Gland.
Time Frame: Day of PAE Procedure
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Day of PAE Procedure
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Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
Time Frame: 3, 12, 24 Months
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3, 12, 24 Months
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Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM).
Time Frame: 12 Months
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The calculation was done using the 12 months mean Sexual Health Inventory for Men (SHIM) score minus the baseline mean SHIM score for paired data (e.g., available data on both baseline and 12 month timepoints).
From the SHIM questionnaire, the total scores was used and range from 1 to 25 with higher scores representing better outcomes (no signs of erectile dysfunction) and lower scores representing worse outcomes (severe erectile dysfunction).
There are a total of 5 questions on the scale and the scores from each question are summed to get a total score.
A positive change score means improvement of outcomes.
'Scores' on a scale is the unite of measure.
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12 Months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAE-P4-17-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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