Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
ID07559630

STRATOS: Randomized Trial of Rectal Arterial Embolization versus Band Ligation for Internal Hemorrhoids

Led by Jessica K. Stewart, MD · Updated on 2026-05-08

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

J

Jessica K. Stewart, MD

Lead Sponsor

T

Terumo Medical Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two standard non-surgical treatments for bleeding internal hemorrhoids: hemorrhoidal artery embolization (HAE) and rubber band ligation (RBL). This study aims to determine which treatment better controls bleeding, reduces symptoms, and improves quality of life. The trial is a single-center, prospective, open-label, randomized study enrolling 40 adults aged 18 to under 90 years with chronic bleeding from Goligher grade II-III internal hemorrhoids who have not responded to conservative treatments. Participants will be randomly assigned to receive either HAE, which uses a catheter to block blood flow to hemorrhoids with tiny particles or coils under conscious sedation, or RBL, which applies rubber bands to cut off blood flow and shrink hemorrhoids. After the initial procedure, follow-up visits occur at 1 week, 1 month, 2 months, 3 months, 6 months, and 12 months. At 6 months, participants still experiencing bleeding may switch to the alternate treatment and follow a similar schedule. During the study, participants will undergo physical exams, vital sign checks, medical history reviews, blood tests, anoscopy, and complete symptom and pain questionnaires. Follow-up visits include repeated symptom assessments, medication reviews, laboratory tests, imaging scans, and monitoring for adverse events. The primary outcome is the number of procedures needed to control bleeding at 6 months. Secondary outcomes include complication rates, time to bleeding control, severe adverse events, treatment satisfaction, and crossover treatments. Participants are followed for up to 18 months in total.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and less than 90 years
  • Ability to provide written informed consent
  • Documented chronic bleeding from internal hemorrhoids
  • Presence of Goligher grade II-III internal hemorrhoids
  • Failed conservative treatments like fiber supplements, topical creams, dietary changes, stool softeners, or warm baths
  • Ability to comply with all treatments and follow-up visits as judged by the principal investigator
Not Eligible

You will not qualify if you...

  • Moderate kidney function loss (eGFR less than 45 mL/min)
  • Significant arterial atherosclerosis limiting angiography
  • Known other causes of gastrointestinal bleeding
  • Allergy to iodinated contrast agents
  • Active infection or cancer
  • Pregnancy
  • Nicotine use within the last 12 months
  • Portal hypertension or rectal varices
  • Uncorrectable blood clotting problems (INR > 2; platelet count <100,000; PTT > 40 seconds)
  • Baseline imaging findings that negatively affect treatment, such as artery stenosis, occlusion, or hypoplasia based on clinical judgment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Initial treatment and up to 6 months of follow-up

Participants undergo treatment with either hemorrhoidal artery embolization or rubber band ligation to control bleeding from internal hemorrhoids.

Initial procedure visit followed by visits at 1 week, 1 month, 2 months, 3 months, and 6 months post-procedure; retreatment visits as needed

Treatment

Duration - Up to 12 months post-crossover treatment

Participants who continue to experience bleeding may crossover to the other treatment modality and undergo a second treatment with similar follow-up.

Visits at 1 week, 1 month, 2 months, 3 months, 6 months, and 12 months post-crossover treatment; retreatment visits as needed

Follow-up

Duration - Up to 18 months total from initial treatment

Participants are followed for up to 18 months to monitor treatment outcomes, adverse events, and satisfaction.

Regular follow-up visits throughout the study period as scheduled

Trial Site Locations

Total: 1 location

1

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

A

Aniket Joglekar, MD

S

Saima Chaabane, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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