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Embosphere® PROstate Post Market Study (PROstate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527589
Recruitment Status : Unknown
Verified February 2021 by Merit Medical Systems, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

Study Description
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Brief Summary:
Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Device: Prostate artery embolization

Detailed Description:
This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months, 24 months and 36 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 499 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : January 26, 2021
Estimated Study Completion Date : January 20, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Device: Prostate artery embolization
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the long-term effectiveness of prostatic artery embolization (PAE) with Embosphere Microspheres as assessed by the International Prostate Symptom Score (IPSS). [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Evaluate IPSS after discontinuation of indwelling bladder catheter (IBC) post PAE. [ Time Frame: 3, 24, 36 Months ]
  2. Evaluate quality of life due to urinary symptoms after discontinuation of indwelling bladder catheter (IBC) post PAE using the I-PSS quality of life assessment index. [ Time Frame: 3, 24, 36 Months ]
  3. Evaluation of device or procedure related adverse events post procedure. [ Time Frame: 3, 12, 24, 36 Months ]
  4. Evaluate frequency of indwelling bladder catheter (IBC) removal post PAE. [ Time Frame: 3, 12, 24, 36 Months ]
  5. Technical Success defined as successful embolization of the treated prostate gland. [ Time Frame: Day of PAE Procedure ]
  6. Evaluation of additional treatments for refractory or recurrent LUTS due to BPH post PAE. [ Time Frame: 3, 12, 24, 36 Months ]
  7. Evaluation of change from baseline in erectile function post PAE using the Sexual Health Inventory for Men (SHIM). [ Time Frame: 12 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only males can receive prostatic artery embolization
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with lower urinary tract sypmtoms (LUTS) due to benign prostatic hyperplasia (BPH)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527589


Locations
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United States, California
VA Long Beach Healthcare Systems
Long Beach, California, United States, 90822
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
University of California Los Angeles
Los Angeles, California, United States, 90095
UC Irvine Health
Orange, California, United States, 92868
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
University of Miami- Miller School of Medicine
Miami, Florida, United States, 33136
United States, Missouri
St. Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, Washington
Providence Sacred Heart
Spokane, Washington, United States, 99204
France
Hôspital Européan Georges Pompidou HEGP
Paris, France, 75015
Italy
Azienda Ospedaliera S. Croce e Carle Cuneo
Cuneo, Italy, 12100
Ospedale Niguarda Ca' Granda
Milano, Italy, 20162
United Kingdom
Churchill Hospital
Headington, Oxford, United Kingdom, OX3 7LE
Frimley Park Hospital
Camberley, Surrey, United Kingdom, GU16 7UJ
Royal Bournemouth and Christchurch Hospital
Bournemouth, United Kingdom, BH7 7DW
Royal Berkshire Hospital
Reading, United Kingdom
Sponsors and Collaborators
Merit Medical Systems, Inc.
More Information
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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT03527589    
Other Study ID Numbers: PAE-P4-17-01
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Merit Medical Systems, Inc.:
Prostatic Artery Embolization
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
PAE
BPH
 LUTS
Embolization
Embolic
Embosphere Microsphere
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations