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NCT Number: NCT07635784

Prospective HemorrhoIdaL EmboliSation (PILES) Registry

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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Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhage Hemorrhoid Bleeding Hemorrhoidal Bleeding Hemorrhoids Internal Hemorrhoid Internal Hemorrhoids Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint and Vascular Institute

Libertyville, Illinois, 60048, United States

Location status: Recruiting

Location contact

Layth Alkhani, BS

CONTACT

[email protected]

847-584-3959

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Hemorrhoidal Disease Symptom Score (HDSS)

    Time frame: 5 years of enrollment/patient

Secondary outcomes

  1. Short Health Scale for hemorrhoidal disease (SHSHD)

    Time frame: 5 years of enrollment/patient

  2. French Bleeding Score (FBS)

    Time frame: 5 years of enrollment/patient

Study contacts

Contact information is provided by the study sponsor or research team.

Layth Alkhani, BS

CONTACT

[email protected]

847-584-3959

Sponsors and collaborators

Lead sponsor

Joint & Vascular Institute

Industry

Registry information

Official study title

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

Acronym: PILES

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jun 9, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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