Evaluating the effects of rectal artery embolization for bleeding hemorrhoids
Hemorrhoidal Embolization Trial-1 (HEMBO-1)
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06106269 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with grade II or III bleeding predominant internal hemorrhoids who have not responded to conservative treatments.
Not a fit: Patients with grade IV hemorrhoidal disease or those who have had prior hemorrhoid surgery may not benefit from this study.
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 performed: While this approach is being systematically evaluated, similar studies have shown promising results with embolization techniques for other vascular conditions.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.