An interventional study of Hemorrhoidal Artery Embolization and Rubber Band Ligation in Hemorrhoidal Bleeding, Hemorrhoids, Internal and HAE, sponsored by Jessica K. Stewart, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Jessica K. Stewart, MD · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Directly comparing these two methods may help to clarify which treatment is better for controlling hemorrhoidal bleeding, reducing symptoms, and improving patients' quality of life.
HAE is a standard minimally invasive procedure to put tiny particles or coils into the blood vessel that feeds a hemorrhoid to block the blood flow (embolization). This involves using a catheter inserted into an artery, using twilight (conscious) sedation.
RBL is a standard procedure that involves using small rubber bands around the base of the hemorrhoids to cut off blood flow, causing it to shrink or shrivel.
A single center, prospective, open-label, double arm, randomized trial to compare rates of control of bleeding from hemorrhoids, during prospective follow-up in patients with internal hemorrhoids undergoing hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL), and the number of procedures needed for hemostasis.
Subjects will be considered enrolled in the study once they have provided informed consent. They will then be randomized to one of two arms after completion of the in-person screening visit. Subjects may proceed to the procedure visit after they have met all screening eligibility criteria.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will then be randomized to HAE or RBL in a 1:1 ratio. A total of 40 subjects will be enrolled in the study and followed for a duration of up to 18 months. All study subjects will undergo the initial procedures, consisting of a physical exam, vital signs, medical history, review of medications, laboratory blood evaluations, anascopy, and completion of completion of the hemorrhoidal disease symptom score (HDSS), the short health scale for hemorrhoidal disease (SHSHD), French bleeding score (FBS), and the visual analog scale (VAS) pain score questionnaires.
After treatment follow-up visits will be at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks) post-procedure. At these visits, subjects will complete all or some of the following: completion of the HDSS, SHSHD, FBS, VAS, and treatment satisfaction questionnaires, review current medications, undergo a directed physical examination, complete laboratory evaluations, anoscopy, CTA abdomen/ pelvis imaging, and report any new adverse events (AEs).
At 6 months, subjects will have the option to crossover because of continued bleeding. Subjects in the crossover group will undergo treatment with the other treatment modality, with follow up at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks).
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →This is the only study on the registry with Jessica K. Stewart, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it.
Device: Hemorrhoidal Artery Embolization
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
Procedure: Rubber Band Ligation
Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it.
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
Number of procedures to control bleeding
To compare rates of control of bleeding from hemorrhoids, based on number of procedures needed for hemostasis, during prospective follow-up in patients with internal hemorrhoids undergoing arterial embolization versus rubber band ligation.
Time frame: 6 months
Complication rates
Number of complications post procedure for each complication type (such as severe pain, thrombosis, or severe bleeding).
Time frame: 0-18 months
Time to control bleeding
Number of weeks to control bleeding post procedure
Time frame: 0-18 months
Severe adverse events
Number of unscheduled ER visits or hospitalization for severe complications.
Time frame: 0-18 months
Patient treatment satisfaction
Treatment satisfaction questionnaire
Time frame: 0-18 months
Number of crossovers
Number of subjects who crossover from rubber band ligation to HAE, or vice versa at 6-months post procedure due to continued bleeding.
Time frame: 0-6 months
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