RecruitingNot Applicable

Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

United States22 participantsStarted 2025-08-05

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score

Timeframe: From baseline to 12 months post procedure

Trial details

NCT IDNCT07179601

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Renato Escobar

310-956-6161 raescobar@mednet.ucla.edu