Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

NCT07179601 | Recruiting FDA Device

• 1 other identifier: 25-0704
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.

Conditions

HAE; Internal Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score

  From baseline to 12 months post procedure

Secondary Outcomes (8)

• Proportion of technically successful HAE procedures

  From baseline to 12 months post procedure

• Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Hemorrhoid Disease Symptom Score (HDSS)

  From baseline to 12 months post procedure

• Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Short Health Scale-Hemorrhoidal Disease (SHSHD)

  From baseline to 12 months post procedure

• Change in pain related to as measured by the Visual Analog Scale (VAS)

  From baseline to 12 months post procedure

• Change in concomitant hemorrhoid medical therapy

  From baseline to 12 months post procedure

Study Arms (1)

Hemorrhoidal artery embolization

EXPERIMENTAL

Patients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids

Procedure: Hemorrhoidal artery embolization

Interventions

Hemorrhoidal artery embolization PROCEDURE

Hemorrhoidal artery embolization (HAE) involves the deliberate blockage of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve symptoms related to internal hemorrhoids, especially bleeding.

Hemorrhoidal artery embolization

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 90 years
• Ability to give written informed consent and to comply with the follow-up visits
• Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine
• Refusal of or contraindication to surgery
• Refusal of or contraindication to other minimally invasive hemorrhoid treatments
• Grade I to III hemorrhoids
• Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year
• Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization

You may not qualify if:

• Asymptomatic patients
• Patients who ever had previous colorectal surgery
• Grade IV hemorrhoids
• Colorectal disease other than hemorrhoids that could result in bleeding
• Anatomic findings on CTA that would preclude successful embolization
• Contraindication to iodinated contrast
• Inability to give written informed consent
• Active infection or malignancy
• Recent (within 12 months) or active cigarette use
• History of inflammatory bowel disease
• Uncorrectable bleeding diathesis
• Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy
• No SRA or MRA supply to the CCR seen intra-procedural angiogram

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (14)

• Ganz RA. The evaluation and treatment of hemorrhoids: a guide for the gastroenterologist. Clin Gastroenterol Hepatol. 2013 Jun;11(6):593-603. doi: 10.1016/j.cgh.2012.12.020. Epub 2013 Jan 16. No abstract available.

  PMID: 23333220 BACKGROUND

• Margetis N. Pathophysiology of internal hemorrhoids. Ann Gastroenterol. 2019 May-Jun;32(3):264-272. doi: 10.20524/aog.2019.0355. Epub 2019 Jan 23.

  PMID: 31040623 BACKGROUND

• Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.

  PMID: 38294832 BACKGROUND

• Cengiz TB, Gorgun E. Hemorrhoids: A range of treatments. Cleve Clin J Med. 2019 Sep;86(9):612-620. doi: 10.3949/ccjm.86a.18079.

  PMID: 31498764 BACKGROUND

• Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014 Aug;109(8):1141-57; (Quiz) 1058. doi: 10.1038/ajg.2014.190. Epub 2014 Jul 15.

  PMID: 25022811 BACKGROUND

• Makris GC, Thulasidasan N, Malietzis G, Kontovounisios C, Saibudeen A, Uberoi R, Diamantopoulos A, Sapoval M, Vidal V. Catheter-Directed Hemorrhoidal Dearterialization Technique for the Management of Hemorrhoids: A Meta-Analysis of the Clinical Evidence. J Vasc Interv Radiol. 2021 Aug;32(8):1119-1127. doi: 10.1016/j.jvir.2021.03.548. Epub 2021 May 7.

  PMID: 33971251 BACKGROUND

• Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28.

  PMID: 24589187 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

• Kucukay MB, Kucukay F. Superior Rectal Artery Embolization with Tris-Acryl Gelatin Microspheres: A Randomized Comparison of Particle Size. J Vasc Interv Radiol. 2021 Jun;32(6):819-825. doi: 10.1016/j.jvir.2021.02.011. Epub 2021 Feb 25.

  PMID: 33640516 BACKGROUND

• Bagla S, Pavidapha A, Lerner J, Kasimcan MO, Piechowiak R, Josovitz K, Marathe A, Isaacson A, Sajan A. Outcomes of Hemorrhoidal Artery Embolization from a Multidisciplinary Outpatient Interventional Center. J Vasc Interv Radiol. 2023 May;34(5):745-749. doi: 10.1016/j.jvir.2023.01.023. Epub 2023 Feb 1.

  PMID: 36736822 BACKGROUND

• Moussa N, Sielezneff I, Sapoval M, Tradi F, Del Giudice C, Fathallah N, Pellerin O, Amouyal G, Pereira H, de Parades V, Vidal V. Embolization of the superior rectal arteries for chronic bleeding due to haemorrhoidal disease. Colorectal Dis. 2017 Feb;19(2):194-199. doi: 10.1111/codi.13430.

  PMID: 27338153 BACKGROUND

• Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.

  PMID: 29724519 BACKGROUND

• Nguyenhuy M, Xu Y, Kok HK, Maingard J, Joglekar S, Jhamb A, Brooks M, Asadi H. Clinical Outcomes Following Rectal Artery Embolisation for the Treatment of Internal Haemorrhoids: A Systematic Review and Meta-Analysis. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1351-1361. doi: 10.1007/s00270-022-03154-7. Epub 2022 May 12.

  PMID: 35551442 BACKGROUND

• Moussa N, Bonnet B, Pereira H, Pechmajou L, Pellerin O, Abed A, Del Giudice C, Dean C, Bouda D, de Parades V, Fathallah N, Sapoval M. Mid-Term Results of Superior Rectal Artery and Coils for Hemorrhoidal Embolization with Particles Bleeding. Cardiovasc Intervent Radiol. 2020 Jul;43(7):1062-1069. doi: 10.1007/s00270-020-02441-5. Epub 2020 Apr 27.

  PMID: 32342155 BACKGROUND

Study Officials

• Lucas Cusumano, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Escobar

CONTACT

310-956-6161; raescobar@mednet.ucla.edu

Lucas Cusumano, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Radiologist, Assistant Clinical Professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 18, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 2, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)