RecruitingNot ApplicableNCT07179601

Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)


Sponsor

University of California, Los Angeles

Enrollment

22 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria8

  • Age 18 to 90 years
  • Ability to give written informed consent and to comply with the follow-up visits
  • Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine
  • 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 demonstrating internal hemorrhoids within 1 year
  • Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization

Exclusion Criteria13

  • Asymptomatic patients
  • Patients who ever had previous colorectal surgery
  • Grade IV hemorrhoids
  • Colorectal disease other than hemorrhoids that could result in bleeding
  • Anatomic findings on CTA that would preclude successful embolization
  • Contraindication to iodinated contrast
  • Inability to give written informed consent
  • Active infection or malignancy
  • Recent (within 12 months) or active cigarette use
  • History of inflammatory bowel disease
  • Uncorrectable bleeding diathesis
  • Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy
  • No SRA or MRA supply to the CCR seen intra-procedural angiogram

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Interventions

PROCEDUREHemorrhoidal artery embolization

Hemorrhoidal artery embolization (HAE) involves the deliberate blockage 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 symptoms related to internal hemorrhoids, especially bleeding.


Locations(1)

University of California, Los Angeles

Los Angeles, California, United States

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NCT07179601


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