Recruiting

HAE vs. RBL

Sponsor:

Jessica K. Stewart, MD

Code:

NCT07559630

Conditions

Hemorrhoidal Bleeding

Hemorrhoids, Internal

HAE

RBL

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hemorrhoidal Artery Embolization

Rubber Band Ligation

Study Details

Brief summary:

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.

Conditions

Hemorrhoidal Bleeding

Hemorrhoids, Internal

HAE

RBL

Study ID

NCT07559630

Start date

May 19, 2026

Status verified date

Jul, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years and less than 90 years.
2. Ability to provide written informed consent.
3. Documented clinical history of chronic bleeding from internal hemorrhoids.
4. Documented presence of Goligher grade II-III internal hemorrhoids.
5. Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
6. Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's.

Exclusion Criteria:

1. Moderate loss of kidney function, defined as estimated glomerular filtration rate of less than 45 mL/min.
2. Significant arterial atherosclerosis that would limit selective angiography.
3. Known alternative causes of GI bleeding.
4. Allergy to iodinated contrast agents.
5. Active infection or malignancy.
6. Pregnancy.
7. Active nicotine use within the last 12 months.
8. Portal hypertension/rectal varices.
9. Uncorrectable coagulopathy (INR > 2; Platelet count <100,000; PTT > 40 sec).
10. Findings on baseline CTA that adversely affect treatment, based on PI's clinical judgment, including but not limited to stenosis, occlusion, or hypoplasia of the superior and/or middle rectal arteries.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hemorrhoidal Artery Embolization

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.

active comparator: Rubber Band Ligation

Involves using a band to cut off blood flow to the hemorrhoid and shrink it.

Interventions

Hemorrhoidal Artery Embolization

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.

Rubber Band Ligation

Involves using a band to cut off blood flow to the hemorrhoid and shrink it.

Primary outcome measure

  • Number of procedures to control bleeding [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

More Information

Sponsor

Jessica K. Stewart, MD

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jessica K. Stewart, MD on 2026-07-10.