Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07179601

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

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating hemorrhoidal artery embolization (HAE), a new procedure for treating symptomatic internal hemorrhoids. HAE works by blocking enlarged arteries in the rectal or hemorrhoidal area to reduce abnormal blood flow, aiming to improve symptoms such as bleeding. Earlier reports suggest HAE may be safe and effective, but more research is needed to understand its long-term effects using different embolization materials in a broader patient population with hemorrhoidal disease. This trial involves 22 patients with grades I to III internal hemorrhoids who have symptoms including a French Bleeding Score of at least four and who have refused or cannot have surgery or other minimally invasive treatments. After an initial clinic visit to confirm eligibility, participants will receive the HAE procedure. The study includes follow-up visits in the clinic at 1, 3, 6, and 12 months after treatment to monitor progress and outcomes. Participants will be assessed for improvements in bleeding symptoms using the French Bleeding Score, as well as changes in other hemorrhoid-related symptoms, pain, and patient satisfaction. Researchers will also track the need for further medical or surgical treatments. Safety and technical success of the HAE procedure will be monitored throughout the year-long study, with all follow-up visits designed to evaluate symptom changes and overall treatment impact.

CONDITIONS

Brief 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 a 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
  • Presence of rectal arterial supply from either the superior or middle rectal artery on angiogram prior to embolization
Not Eligible

You will not qualify if you...

  • No symptoms of hemorrhoids
  • History of previous colorectal surgery
  • Grade IV hemorrhoids
  • Other colorectal diseases causing bleeding
  • Anatomic findings on CT angiogram preventing successful embolization
  • Contraindication to iodinated contrast
  • Unable to give written informed consent
  • Active infection or cancer
  • Recent or active cigarette use within 12 months
  • History of inflammatory bowel disease
  • Uncorrectable bleeding disorder
  • Portal hypertension or rectal varices seen on imaging or endoscopy
  • Absence of arterial supply to hemorrhoidal tissue on angiogram

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of procedure

Participants undergo hemorrhoidal artery embolization (HAE), a procedure that blocks enlarged arteries to reduce symptoms of internal hemorrhoids.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for safety and symptom improvement with clinic visits following the treatment.

Follow-up visits at 1, 3, 6, and 12 months post-procedure (4 visits, in-person)

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

L

Lucas Cusumano, MD

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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Published Research Related To This Trial

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids.

Alexander T Hawkins, Bradley R Davis, Anuradha R Bhama...

https://pubmed.ncbi.nlm.nih.gov/38294832

Catheter-Directed Hemorrhoidal Dearterialization Technique for the Management of Hemorrhoids: A Meta-Analysis of the Clinical Evidence.

Gregory C Makris, Narayan Thulasidasan, George Malietzis...

https://pubmed.ncbi.nlm.nih.gov/33971251

Superior Rectal Artery Embolization with Tris-Acryl Gelatin Microspheres: A Randomized Comparison of Particle Size.

Murat Bülent Küçükay, Fahrettin Küçükay

https://pubmed.ncbi.nlm.nih.gov/33640516