Prospective HemorrhoIdaL EmboliSation (PILES) Registry (PILES)

June 4, 2026 updated by: Joint & Vascular Institute

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

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 knee osteoarthritis in adults aged 18 years or older with symptomatic bleeding internal hemorrhoids 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Libertyville, Illinois, United States, 60048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients (18 years and older) presenting to the Joint & Vascular Institute for clinical consultation regarding symptomatic internal hemorrhoids. This population includes individuals who have failed standard medical management (such as dietary modifications, topical therapies, or office-based procedures) and are seeking minimally invasive alternatives to surgical hemorrhoidectomy. The registry will include men and women of all races and ethnicities without exclusion, provided they meet the clinical criteria for Hemorrhoidal Artery Embolization (HAE) as determined by the Principal Investigator or Sub-Investigators.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemorrhoidal Disease Symptom Score (HDSS)
Time Frame: 5 years of enrollment/patient
5 years of enrollment/patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Short Health Scale for hemorrhoidal disease (SHSHD)
Time Frame: 5 years of enrollment/patient
5 years of enrollment/patient
French Bleeding Score (FBS)
Time Frame: 5 years of enrollment/patient
5 years of enrollment/patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint & Vascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1395380

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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