RecruitingNot Applicable

Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids

United States20 participantsStarted 2024-06-07

Plain-language summary

This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.

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: * Grade II or III hemorrhoidal disease as determined by a board-certified colorectal surgeon. * Persistent or recurrent symptoms following hygiene and dietary measures or medication. * Bleeding predominant ± pain symptoms. * Undergoing planned rectal artery embolization (RAE) per standard clinical care. * Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent. * Negative pregnancy test (if applicable). Exclusion Criteria: * Prior hemorrhoid surgery. * Grade IV hemorrhoidal disease. * Acute hemorrhoid complications. * Chronic anal or perianal fissures. * History of colorectal surgery or pelvic radiation. * Inflammatory bowel disease. * Portal hypertension or mesenteric venous congestion/occlusion. * Inferior mesenteric artery (IMA) or internal iliac artery (IIA) stenosis or occlusion. * Contraindication to iodinated contrast. * Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure per clinical care.

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

Change in French bleeding score (FBS)

Timeframe: Baseline, 1, 3, 6 and 12 months

Adverse Events

Timeframe: Day 1 and 1, 3, 6 and 12 months

Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)

Timeframe: Baseline (pre-embolization)

Trial details

NCT IDNCT06106269

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Desirae Howe-Clayton

507-255-0111 Howe.Desirae@mayo.edu

View on ClinicalTrials.gov More Internal Hemorrhoid trials

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.