Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

Recruiting now · Not applicable

Conditions studied: Internal Hemorrhoids, HAE

In brief

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.

Key facts

Study ID

NCT07179601

Run by

University of California, Los Angeles

People needed

22

Starts

2025-08-05

Expected to finish

2029-09-30

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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