Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07179601

Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

Led by University of California, Los Angeles · Updated on 2026-02-02

22

Participants Needed

1

Research Sites

216 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.

CONDITIONS

Official Title

Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 90 years
  • Ability to give written informed consent and comply with follow-up visits
  • Symptomatic hemorrhoidal disease with French Bleeding Score of at least 4 out of 9
  • Refusal of or contraindication to surgery
  • Refusal of or contraindication to other minimally invasive hemorrhoid treatments
  • Grade I to III hemorrhoids
  • Previous anoscopy or colonoscopy showing internal hemorrhoids within 1 year
  • Supply of the common rectal artery (CCR) from either the superior rectal artery (SRA) or middle rectal artery (MRA) seen on intra-procedural angiogram before embolization
Not Eligible

You will not qualify if you...

  • Asymptomatic patients
  • Previous colorectal surgery
  • Grade IV hemorrhoids
  • Colorectal disease other than hemorrhoids that could cause bleeding
  • Anatomic findings on CTA that prevent successful embolization
  • Contraindication to iodinated contrast
  • Inability to give written informed consent
  • Active infection or malignancy
  • Recent or active cigarette use within 12 months
  • History of inflammatory bowel disease
  • Uncorrectable bleeding disorders
  • Presence of portal hypertension or rectal varices on pre-procedure CTA or anoscopy/colonoscopy
  • No supply of CCR from SRA or MRA seen on intra-procedural angiogram

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

R

Renato Escobar

CONTACT

L

Lucas Cusumano, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS) | DecenTrialz