NCT07559630 · Jessica K. Stewart, MD
Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
(STRATOS)
What this study is about
The purpose of this clinical trial is to compare two the usual treatment 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.
View original scientific description
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.
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
- Age ≥ 18 years and less than 90 years.
- Ability to provide written informed consent.
- Documented clinical history of chronic bleeding from internal hemorrhoids.
- Documented presence of Goligher grade II-III internal hemorrhoids.
- Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
- Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's.
Exclusion criteria
- Moderate loss of kidney function, defined as estimated glomerular filtration rate of less than 45 mL/min.
- Significant arterial atherosclerosis that would limit selective angiography.
- Known alternative causes of GI bleeding.
- Allergy to iodinated contrast agents.
- Active infection or malignancy.
- Active nicotine use within the last 12 months.
- Portal hypertension/rectal varices.
- Uncorrectable coagulopathy (INR \> 2; Platelet count \<100,000; PTT \> 40 sec).
- 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.
Where
- Los Angeles, California
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 Jul 10, 2026 · Source of record for eligibility and locations