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Prospective HemorrhoIdaL EmboliSation (PILES) Registry

NCT07635784 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

  • Hemorrhoid
  • Internal Hemorrhoids
  • Hemorrhoid Bleeding
  • Hemorrhoidal Bleeding
  • Internal Hemorrhoid

Interventions

PROCEDURE

Hemorrhoid 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.

Sponsors & Collaborators

  • Joint & Vascular Institute

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-18
Primary Completion
2031-01-31
Completion
2032-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635784 on ClinicalTrials.gov