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Embosphere® PROstate Post Market Study

NCT ID: NCT03527589

Last Updated: 2023-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

499 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2022-01-22

Brief Summary

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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.

Detailed Description

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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 and 24 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.

Conditions

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Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Keywords

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Prostatic Artery Embolization (PAE) Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptoms (LUTS) Embolization Embolic Embosphere Microsphere

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Prostate artery embolization

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA Long Beach Healthcare Systems

Long Beach, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

UC Irvine Health

Orange, California, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

University of Miami- Miller School of Medicine

Miami, Florida, United States

Site Status

St. Louis University Hospital

St Louis, Missouri, United States

Site Status

Providence Sacred Heart

Spokane, Washington, United States

Site Status

Hôspital Européan Georges Pompidou HEGP

Paris, , France

Site Status

Azienda Ospedaliera S. Croce e Carle Cuneo

Cuneo, , Italy

Site Status

Ospedale Niguarda Ca' Granda

Milan, , Italy

Site Status

Churchill Hospital

Headington, Oxford, United Kingdom

Site Status

Frimley Park Hospital

Camberley, Surrey, United Kingdom

Site Status

Royal Bournemouth and Christchurch Hospital

Bournemouth, , United Kingdom

Site Status

Royal Berkshire Hospital

Reading, , United Kingdom

Site Status

Countries

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United States France Italy United Kingdom

References

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Sapoval MR, Bhatia S, Dean C, Rampoldi A, Carnevale FC, Bent C, Tapping CR, Bongiovanni S, Taylor J, Brower JS, Rush M, McWilliams JP, Little MW; PROstate Study Investigators. Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study. Cardiovasc Intervent Radiol. 2024 Nov;47(11):1515-1524. doi: 10.1007/s00270-024-03802-0. Epub 2024 Sep 4.

Reference Type DERIVED
PMID: 39230672 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PAE-P4-17-01

Identifier Type: -

Identifier Source: org_study_id