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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03527589
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc.

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 Phase
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Device: Prostate embolization with Embosphere Microspheres Phase 4

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 1,000 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 treatment 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.

Eligibility Criteria Inclusion Criteria

  • Patient has signed informed consent
  • Patient age is 18 years or older at time of informed consent
  • Patient will undergo PAE with Embosphere Microspheres for the treatment of symptomatic BPH with LUTS

Exclusion Criteria

  • Patient is unable or unwilling to provide follow-up information
  • Patient is undergoing PAE for reasons that do not include symptomatic BPH with LUTS
  • Any other reason the investigator deems cause for exclusion

A treatment-related adverse event is defined in this post market study as any event that began on or after the date of the PAE procedure and is considered related to the study procedure by the investigator. All related events must be reported in the case report form and followed until resolution.Any treatment-related serious adverse events (SAE) that occurs on or after the date of the PAE or worsened in severity or frequency after the PAE must be reported to the Sponsor immediately (not to exceed 24 hours within site notification of the event) in the case report form or via email. It is the responsibility of Investigators to inform their Review Board/ Ethics Committee (IRB/EC) of complications or serious injury as required by their Institutional Review Board/ Ethics Committee (IRB/EC) procedure and/or federal law.

After the study has been fully explained, written informed consent will be obtained from either the patient or his guardian or legal representative prior to any study procedures. The method of obtaining and documenting the informed consent and the contents of the consent will comply with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and all applicable regulatory requirement(s).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 embolization with Embosphere Microspheres
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.




Primary Outcome Measures :
  1. Evaluation of effectiveness as determined by International Prostate Symptom Score measurement at 3 months as compared to baseline [ Time Frame: 3 Months ]
    The International Prostate Symptom Score will be self-administered by the patient, and will be used to determine effectiveness of the treatment as compared to baseline.

  2. Evaluation of effectiveness as determined by International Prostate Symptom Score measurement at 12 months as compared to baseline [ Time Frame: 12 Months ]
    The International Prostate Symptom Score will be self-administered by the patient, and will be used to determine effectiveness of the treatment as compared to baseline.

  3. Evaluation of effectiveness as determined by International Prostate Symptom Score measurement at 24 months as compared to baseline [ Time Frame: 24 Months ]
    The International Prostate Symptom Score will be self-administered by the patient, and will be used to determine effectiveness of the treatment as compared to baseline.

  4. Evaluation of effectiveness as determined by International Prostate Symptom Score measurement at 36 months as compared to baseline [ Time Frame: 36 Months ]
    The International Prostate Symptom Score will be self-administered by the patient, and will be used to determine effectiveness of the treatment as compared to baseline.


Secondary Outcome Measures :
  1. Erectile Function as determined by Sexual Health Inventory for Men measurement at 3 months as compared to baseline [ Time Frame: 3 Months ]
    The Sexual Health Inventory for Men will be self-administered by the patient and will be used to determine erectile function as compared to baseline.

  2. Erectile Function as determined by Sexual Health Inventory for Men measurement at 12 months as compared to baseline [ Time Frame: 12 Months ]
    The Sexual Health Inventory for Men will be self-administered by the patient and will be used to determine erectile function.

  3. Erectile Function as determined by Sexual Health Inventory for Men measurement at 24 months as compared to baseline [ Time Frame: 24 Months ]
    The Sexual Health Inventory for Men will be self-administered by the patient and will be used to determine erectile function.

  4. Erectile Function as determined by Sexual Health Inventory for Men measurement at 3 months as compared to baseline [ Time Frame: 36 Months ]
    The Sexual Health Inventory for Men will be self-administered by the patient and will be used to determine erectile function.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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

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


Contacts
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Contact: Casey Holland (781) 681-7983 casey.holland@merit.com
Contact: Joselyn Cerezo (781) 681-7923 joselyn.cerezo@merit.com

Locations
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United States, California
VA Long Beach Healthcare Systems Recruiting
Long Beach, California, United States, 90822
Contact: Katherine Isip       Katherine.Isip@va.gov   
Principal Investigator: Edward Uchio, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Stephanie Gilbert       SGilbert@mednet.ucla.edu   
Contact: Victoria Rueda       VRueda@mednet.ucla.edu   
Principal Investigator: Justin McWilliams, MD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Stephanie Gilbert       sgilbert@mednet.ucla.edu   
Principal Investigator: Justin McWilliams, MD         
UC Irvine Health Recruiting
Orange, California, United States, 92868
Contact: Steven Bereta, MS, RN, FNP-C       sbereta@uci.edu   
Principal Investigator: Edward Uchio, MD         
Sub-Investigator: James Katrivesis, MD         
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Cyndi Toot       cynthia.toot@holy-cross.com   
Principal Investigator: Michael Rush         
University of Miami- Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Lia Quezada       LQuezada@med.miami.edu   
Principal Investigator: Shivank Bhatia         
United States, Missouri
St. Louis University Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Anna Hardy, RN    314-268-5785    anna.hardy@health.slu.edu   
Principal Investigator: Kirubahara Vaheesan, MD         
Sub-Investigator: Keith Pereira, MD         
United States, New York
Columbia Presbyterian Medical Center Withdrawn
New York, New York, United States, 10032
United States, Washington
Providence Sacred Heart Recruiting
Spokane, Washington, United States, 99204
Contact: Erik Kollarsky, RN, BSN       erik.kollarsky@providence.org   
Principal Investigator: Jayson Brower, MD         
France
Hôspital Européan Georges Pompidou HEGP Recruiting
Paris, France, 75015
Contact: Kahina Kabri       kahina.kabri@aphp.fr   
Principal Investigator: Marc Sapoval, MD         
Italy
Azienda Ospedaliera S. Croce e Carle Cuneo Recruiting
Cuneo, Italy, 12100
Contact: Simone Bongiovanni       simone.bongio@gmail.com   
Principal Investigator: Maurizio Grosso, MD         
Ospedale Niguarda Ca' Granda Recruiting
Milano, Italy, 20162
Contact: Pietro Brambilasca       pietro.brambillasca90@gmail.com   
Principal Investigator: Antonio Rampoldi, MD         
United Kingdom
Churchill Hospital Recruiting
Headington, Oxford, United Kingdom, OX3 7LE
Contact: Sarah Crosbie    1865225781    sarah.crosbie@ouh.nhs.uk   
Principal Investigator: Charles Ross Tapping, MD         
Frimley Park Hospital Recruiting
Camberley, Surrey, United Kingdom, GU16 7UJ
Contact: Alexandra Edwards    01276526779    alexandra.edwards3@nhs.net   
Principal Investigator: Jeremy Taylor, MD         
Royal Bournemouth and Christchurch Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Contact: Luke Vamplew    01202726127    luke.vamplew@rbch.nhs.uk   
Principal Investigator: Clare Bent, MD         
Royal Berkshire Hospital Recruiting
Reading, United Kingdom
Contact: Sarah MacGill       sarah.macgill@royalberkshire.nhs.uk   
Principal Investigator: Mark Little, MD         
Sponsors and Collaborators
Merit Medical Systems, Inc.

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Responsible Party: Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT03527589     History of Changes
Other Study ID Numbers: PAE-P4-17-01
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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
Urological Manifestations
Signs and Symptoms