RecruitingNCT07635784

Prospective HemorrhoIdaL EmboliSation (PILES) Registry

Creation Of a Prospective Registry For Hemorrhoid Artery Embolization At The Joint & Vascular Institute


Sponsor

Joint & Vascular Institute

Enrollment

1,200 participants

Start Date

Jan 18, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study (prospective registry) is to collect long-term real-world data on the effectiveness and safety of hemorrhoid artery embolization (HAE) for symptomatic bleeding internal hemorrhoids in adults aged 18 years or older that have not responded to medical therapy. The main question it aims to answer are: 1\) Does HAE lead to sustained improvement in bleeding (HDSS scores over 12-36 months? Participants will: * Undergo HAE as part of their routine clinical care. * Complete clinical follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months after treatment, including symptom and quality-of-life questionnaires. * Have safety outcomes tracked according to Society of Interventional Radiology guidelines. There is no comparison group; results will be analyzed to identify predictors of success and inform best practices for patient selection and treatment.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.

Exclusion Criteria1

  • Pregnancy, coagulopathy, severe comorbidities, or inability to consent.

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Interventions

PROCEDUREHemorrhoid Artery Embolization

Hemorrhoidal Artery Embolization (HAE)-often referred to clinically as the Emborrhoid technique-is a minimally invasive, image-guided procedure in which embolic agents are delivered into the superior rectal arteries to reduce hypervascular blood flow, thereby shrinking engorged hemorrhoidal plexuses and alleviating chronic bleeding and discomfort from internal hemorrhoids.


Locations(1)

Joint and Vascular Institute

Libertyville, Illinois, United States

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NCT07635784


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