NCT06106269 · Mayo Clinic
Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids
(HEMBO-1)
What this study is about
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
View original scientific description
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
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
- 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
- Rochester, Minnesota
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 Jun 17, 2026 · Source of record for eligibility and locations