Evaluating the effects of rectal artery embolization for bleeding hemorrhoids
Official title: Hemorrhoidal Embolization Trial-1 (HEMBO-1)
Run by Mayo Clinic · NCT06106269 · Data updated 2026-11-12
This study is testing if a procedure called rectal artery embolization can help adults with bleeding hemorrhoids feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | June 7, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT06106269 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with grade II or III bleeding predominant internal hemorrhoids who have not responded to conservative treatments.
✕Probably not a fit
Patients with grade IV hemorrhoidal disease or those who have had prior hemorrhoid surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the effectiveness and safety of rectal artery embolization in treating symptomatic bleeding predominant internal hemorrhoids. It will involve 20 adult patients with grade II or III hemorrhoids who are referred for this procedure. Participants will undergo a series of evaluations, including baseline assessments and follow-ups at 1, 3, 6, and 12 months post-procedure, to measure outcomes and quality of life. The study will be conducted at the Mayo Clinic, where patients will receive standard clinical care alongside research evaluations.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from bleeding hemorrhoids.
How similar studies have gone: While this approach is being systematically evaluated, similar studies have shown promising results with embolization techniques for other vascular conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Mayo Clinic Minnesota
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Scott Thompson, MD, PhD — Mayo Clinic, Vascular and Interventional Radiology
- Study coordinator: Desirae Howe-Clayton
- Email: Howe.Desirae@mayo.edu
- Phone: 507-255-0111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.