Prospective HemorrhoIdaL EmboliSation (PILES) Registry

NCT07635784 — Recruiting, 1200 participants, Joint & Vascular Institute

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

Registry	NCT07635784, acronym PILES
Status	Recruiting
Study type	Observational
Enrollment	1200 (Estimated)
Sponsor	Joint & Vascular Institute (Industry)
Conditions	Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding, Hemorrhoidal Bleeding, Internal Hemorrhoid
Interventions	Hemorrhoid Artery Embolization (Procedure)
Dates	start 2026-01-18, primary completion 2031-01-01 (estimated), completion 2032-01-01 (estimated), first posted 2026-06-09, last updated 2026-06-12
Locations	1 site in United States

-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.

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+Arms and interventions

Hemorrhoid Artery Embolization (Procedure): 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.

+Outcome measures

Primary outcomes

Hemorrhoidal Disease Symptom Score (HDSS) [5 years of enrollment/patient]

Secondary outcomes

Short Health Scale for hemorrhoidal disease (SHSHD) [5 years of enrollment/patient]
French Bleeding Score (FBS) [5 years of enrollment/patient]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Joint and Vascular Institute	Libertyville, Illinois	United States	Recruiting