NCT07179601 Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
| NCT ID | NCT07179601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Internal Hemorrhoids |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2025-08-05 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Lucas Cusumano, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT07179601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Internal Hemorrhoids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07179601 currently recruiting?
Yes, NCT07179601 is actively recruiting participants. Contact the research team at raescobar@mednet.ucla.edu for enrollment information.
Where is the NCT07179601 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07179601 clinical trial?
NCT07179601 is sponsored by University of California, Los Angeles. The principal investigator is Lucas Cusumano, MD at University of California, Los Angeles. The trial plans to enroll 22 participants.