Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS (STRATOS)

May 6, 2026 updated by: Jessica K. Stewart, MD

STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Procedure: Rubber Band Ligation
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of procedures to control bleeding
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rates
Time Frame: 0-18 months
Number of complications post procedure for each complication type (such as severe pain, thrombosis, or severe bleeding).
0-18 months
Time to control bleeding
Time Frame: 0-18 months
Number of weeks to control bleeding post procedure
0-18 months
Severe adverse events
Time Frame: 0-18 months
Number of unscheduled ER visits or hospitalization for severe complications.
0-18 months
Number of crossovers
Time Frame: 0-6 months
Number of subjects who crossover from rubber band ligation to HAE, or vice versa at 6-months post procedure due to continued bleeding.
0-6 months
Patient treatment satisfaction
Time Frame: 0-18 months
Treatment satisfaction questionnaire
0-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessica K. Stewart, MD

Collaborators

Terumo Medical Corporation

Investigators

  • Principal Investigator: Jessica Stewart, MD, University of California, Los Angeles
  • Principal Investigator: Dennis Jensen, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 29, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2437

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HAE

Clinical Trials on Hemorrhoidal Artery Embolization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe