Recruiting

Hemorrhoidal Artery EmbolizationHemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

Sponsor:

UCLA

Code:

NCT07179601

Conditions

Internal Hemorrhoids

HAE

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hemorrhoidal artery embolization

Study Details

Brief 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.

Conditions

Internal Hemorrhoids

HAE

Study ID

NCT07179601

Start date

Aug 5, 2025

Status verified date

Oct, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hemorrhoidal artery embolization

Patients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids

Interventions

Hemorrhoidal 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.

Primary outcome measure

Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score [ Time Frame: From baseline to 12 months post procedure ]

Central Contacts and Locations

Central contacts

Renato Escobar

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

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Renato Escobar, BS

raescobar@mednet.ucla.edu

Saima Chaabane, PhD

SChaabane@mednet.ucla.edu

Principal Investigator:

Lucas Cusumano, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 2, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-02.