Hemorrhoidal artery embolization to improve internal hemorrhoid symptoms
Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
This trial will try blocking enlarged hemorrhoidal arteries to reduce bleeding and other symptoms in adults with symptomatic internal hemorrhoids who cannot or will not have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07179601 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults age 18–90 with symptomatic internal hemorrhoids (Grade I–III) and a French Bleeding Score of at least 4 who cannot or will not undergo surgery or other minimally invasive hemorrhoid treatments are the ideal candidates.
Not a fit: Patients with Grade IV hemorrhoids, prior colorectal surgery, other colorectal conditions that cause bleeding, active infection or malignancy, recent or active smoking, or contraindication to iodinated contrast are excluded and unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, HAE could reduce hemorrhoid bleeding and other symptoms and offer a less invasive option than surgery for suitable patients.
How similar studies have performed: Early reports and small series have suggested HAE can be safe and effective, but prospective long-term data in broader patient groups are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.