Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
NCT07559630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-08
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
Interventions
- 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.
- PROCEDURE
-
Rubber Band Ligation
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
Sponsors & Collaborators
-
Terumo Medical Corporation
collaborator INDUSTRY -
Jessica K. Stewart, MD
lead OTHER
Principal Investigators
-
Jessica Stewart, MD · University of California, Los Angeles
-
Dennis Jensen, MD · University of California, Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-29
- Primary Completion
- 2030-11-30
- Completion
- 2031-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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