Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
NCT ID: NCT07179601
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
22 participants
INTERVENTIONAL
2025-08-05
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hemorrhoidal artery embolization
Patients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids
Hemorrhoidal artery embolization
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.
Interventions
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Hemorrhoidal artery embolization
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Lucas R. Cusumano, MD
Interventional Radiologist, Assistant Clinical Professor
Principal Investigators
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Lucas Cusumano, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Countries
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Central Contacts
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Lucas Cusumano, MD
Role: CONTACT
Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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25-0704
Identifier Type: -
Identifier Source: org_study_id
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