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

NCT07559630 | Recruiting FDA Device

• 1 other identifier: 25-2437
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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; HAE; RBL; Hemorrhoids, Internal

Outcome Measures

Primary Outcomes (1)

• Number of procedures to control bleeding

  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 Outcomes (5)

• Complication rates

  0-18 months

• Time to control bleeding

  0-18 months

• Severe adverse events

  0-18 months

• Patient satisfaction

  0-18 months

• Number of crossovers

  0-6 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Hemorrhoidal Artery Embolization

Device: Hemorrhoidal Artery Embolization

Arm B

ACTIVE COMPARATOR

Rubber Band Ligation

Procedure: Rubber Band Ligation

Interventions

Rubber Band Ligation PROCEDURE

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

Arm B

Hemorrhoidal Artery Embolization DEVICE

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.

Arm A

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy.
• 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.

Sponsors & Collaborators

• Jessica K. Stewart, MD: lead
• Terumo Medical Corporation: collaborator

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (8)

• Yan Z, Gui Y, Liu C, Zhang X, Wen C, Olatunji OJ, Suttikhana I, Ashaolu TJ. Gastrointestinal digestion of food proteins: Anticancer, antihypertensive, anti-obesity, and immunomodulatory mechanisms of the derived peptides. Food Res Int. 2024 Aug;189:114573. doi: 10.1016/j.foodres.2024.114573. Epub 2024 May 28.

  PMID: 38876600 BACKGROUND

• Watanabe N, Hirose M, Hasegawa A, Mochida K, Ogura A, Inoue K. Derivation of embryonic stem cells from wild-derived mouse strains by nuclear transfer using peripheral blood cells. Sci Rep. 2023 Jul 10;13(1):11175. doi: 10.1038/s41598-023-38341-0.

  PMID: 37430017 BACKGROUND

• Douek M. Radiofrequency Ablation of Solid, Non-Functional Thyroid Nodules. Tech Vasc Interv Radiol. 2022 Jun;25(2):100821. doi: 10.1016/j.tvir.2022.100821. Epub 2022 Mar 15. No abstract available.

  PMID: 35551805 BACKGROUND

• Talaie R, Torkian P, Moghadam AD, Tradi F, Vidal V, Sapoval M, Golzarian J. Hemorrhoid embolization: A review of current evidences. Diagn Interv Imaging. 2022 Jan;103(1):3-11. doi: 10.1016/j.diii.2021.07.001. Epub 2021 Aug 27.

  PMID: 34456172 BACKGROUND

• Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol. 2012 May 7;18(17):2009-17. doi: 10.3748/wjg.v18.i17.2009.

  PMID: 22563187 BACKGROUND

• Panneau J, Mege D, Di Bisceglie M, Duclos J, Habert P, Bartoli A, Vidal V, Tradi F. Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques. Radiographics. 2022 Oct;42(6):1829-1844. doi: 10.1148/rg.220014.

  PMID: 36190848 BACKGROUND

• Sandler RS, Peery AF. Rethinking What We Know About Hemorrhoids. Clin Gastroenterol Hepatol. 2019 Jan;17(1):8-15. doi: 10.1016/j.cgh.2018.03.020. Epub 2018 Mar 27.

  PMID: 29601902 BACKGROUND

• Jutabha R, Jensen DM, Chavalitdhamrong D. Randomized prospective study of endoscopic rubber band ligation compared with bipolar coagulation for chronically bleeding internal hemorrhoids. Am J Gastroenterol. 2009 Aug;104(8):2057-64. doi: 10.1038/ajg.2009.292. Epub 2009 Jun 9.

  PMID: 19513028 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jessica Stewart, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Dennis Jensen, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aniket Joglekar, MD

CONTACT

310-948-8026; ajoglekar@mednet.ucla.edu

Saima Chaabane, PhD

CONTACT

424-465-4482; SChaabane@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 40 subjects will be enrolled in the double-arm study, subjects will be randomized to HAE or RBL in a 1:1 ratio (20 assigned to HAE, 20 assigned to RBL). Subjects in the either arm will have the option to crossover to the other treatment modality if bleeding is not controlled by their 6-month follow-up time point. Subjects who crossover undergo the other treatment and undergo follow-up visits at \[1 week, 1 month, retreatment (if needed), 2 month, 3 month, 6 month, and 12 months\].

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)