Hemorrhoidal artery embolization to improve internal hemorrhoid symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Hemorrhoidal artery embolization (HAE) is a minimally invasive procedure that deliberately blocks enlarged rectal or hemorrhoidal arteries to reduce abnormal blood flow to hemorrhoidal tissue and lessen symptoms, especially bleeding. This single-arm interventional project will enroll 22 adults with symptomatic internal hemorrhoids (Grade I–III, French Bleeding Score ≥4) who have refused or are contraindicated for surgery or other minimally invasive treatments. Enrolled patients will undergo HAE and be followed with clinic visits at 1, 3, 6, and 12 months to monitor symptom changes and safety. The study aims to provide prospective, longer-term data on symptom outcomes and the effects of embolization materials in a broader patient population than prior reports.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Lucas Cusumano, MD — University of California, Los Angeles
• Study coordinator: Renato Escobar
• Email: raescobar@mednet.ucla.edu
• Phone: 310-956-6161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• STOP-HAE: ADX-324 for hereditary angioedema

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.