CompletedNot Applicable

Embosphere® PROstate Post Market Study

United States499 participantsStarted 2018-08-16

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).

Timeframe: 12 Months

Trial details

NCT IDNCT03527589

SponsorMerit Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-01-21

Results submitted2022-05-05

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials