Prospective HemorrhoIdaL EmboliSation (PILES) Registry

NCT07635784 | Recruiting

• 1 other identifier: 1395380
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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; Hemorrhoid Bleeding; Hemorrhoidal Bleeding; Internal Hemorrhoid; Internal Hemorrhoids

Keywords

bleeding; hemorrhoids; internal hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Hemorrhoidal Disease Symptom Score (HDSS)

  5 years of enrollment/patient

Secondary Outcomes (2)

• Short Health Scale for hemorrhoidal disease (SHSHD)

  5 years of enrollment/patient

• French Bleeding Score (FBS)

  5 years of enrollment/patient

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Joint & Vascular Institute: lead

Study Sites (1)

Joint and Vascular Institute

Libertyville, Illinois, 60048, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhoids; Hemorrhage

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Layth Alkhani, BS

CONTACT

847-584-3959; lalkhani@jointvascular.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: January 18, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)