NCT07179601 · University of California, Los Angeles
Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
(HELIOS)
What this study is about
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.
View original scientific 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 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations