Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
United States22 participantsStarted 2025-08-05
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score
Timeframe: From baseline to 12 months post procedure