Status:
RECRUITING
Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
Lead Sponsor:
University of California, Los Angeles
Conditions:
Internal Hemorrhoids
HAE
Eligibility:
All Genders
18-90 years
Phase:
NA
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 leadin...
Detailed Description
Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leadin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT07179601
Start Date
August 5 2025
End Date
September 30 2029
Last Update
October 16 2025
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095