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Internal HemorrhoidsHELIOSNCT07179601

Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

A study testing Hemorrhoidal artery embolization in people with Internal Hemorrhoids and HAE, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Internal Hemorrhoids, HAE
What is being tested?
Hemorrhoidal artery embolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
5 Aug 2025to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lucas Cusumano, MD contact

United States1 site, 1 recruiting
  • University of California, Los Angeles

    Los Angeles, California, 90095

    Renato Escobar, BS, raescobar@mednet.ucla.edu

    Saima Chaabane, PhD, SChaabane@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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. However, the initial data is limited due to variations in embolization techniques, few studies with prospective long-term follow-up, and studies focusing on patients with only severe symptoms. Further research is needed to understand the specific long-term effectiveness of different embolization materials in a population that more accurately reflects the large number of patients with hemorrhoidal disease who would likely benefit from HAE. The proposed research project includes 22 patients with symptomatic internal hemorrhoids. 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.

Being tested
Hemorrhoidal artery embolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemorrhoidal artery embolizationProcedure or surgery

    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.

Study groups in NCT07179601
Study groupRoleWhat they receive
Hemorrhoidal artery embolizationExperimentalPatients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids
Receives: Procedure: Hemorrhoidal artery embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From baseline to 12 months post procedure

Secondary outcomes (8)
  1. Proportion of technically successful HAE procedures

    Measured: From baseline to 12 months post procedure

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

    The Hemorrhoidal Disease Symptom Score (HHDS) is a widely used questionnaire used by health professionals to evaluate the condition of patients with hemorrhoids. It can be self-administered and asks patients to rate the frequency and intensity of five primary symptoms: pain, itching, bleeding, soiling, and prolapse. Each symptom is rated on a scale of 0 to 4, with 0 indicating no symptoms and 4 indicating the most severe symptoms. The total HDSS score ranges from 0 to 20, with higher scores indicating more severe hemorrhoidal disease.

    Measured: From baseline to 12 months post procedure

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

    The Short Health Scale-Hemorrhoidal Disease questionnaire is a validated tool used to assess the impact of hemorrhoidal disease on a patient's health-related quality of life. It can be self-administered and measures four key dimensions: symptom load, functional status, disease-specific worries, and general well-being. Each symptom is rated on a scale of 1 to 7, with 1 indicating no symptoms and 7 indicating the most severe symptoms. The total SHSHD score ranges from 4 to 28, with higher scores indicating more severe hemorrhoidal disease.

    Measured: From baseline to 12 months post procedure

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

    The Visual Analog Scale (VAS) is a validated commonly used pain score. The VAS ranges from 0 to 10, with higher scores indicated higher pain levels.

    Measured: From baseline to 12 months post procedure

  5. Change in concomitant hemorrhoid medical therapy

    Measured: From baseline to 12 months post procedure

  6. Level of patient satisfaction after HAE as determined by patient satisfaction questionnaire

    Patient satisfaction will be determined by a patient satisfaction questionnaire with the following four options: very satisfied, satisfied, a little satisfied, and unsatisfied

    Measured: From baseline to 12 months post procedure

  7. Proportion of patients requiring subsequent non-surgical internal hemorrhoid procedures

    Measured: From baseline to 12 months post procedure

  8. Proportion of patients requiring surgical management of their internal hemorrhoids

    Measured: From baseline to 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start5 Aug 2025
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07179601
Sponsor's protocol ID
25-0704
Acronym
HELIOS
Status last verified
Oct 2025
First submitted
16 Sep 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23333220
  • 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.

    PubMed 31040623
  • 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.

    PubMed 38294832
  • 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.

    PubMed 31498764
  • 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.

    PubMed 25022811
  • 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.

    PubMed 33971251
  • 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.

    PubMed 24589187
  • 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.

    PubMed 36190848
  • 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.

    PubMed 33640516
  • 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.

    PubMed 36736822
  • 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.

    PubMed 27338153
  • 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.

    PubMed 29724519
  • 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.

    PubMed 35551442
  • 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.

    PubMed 32342155

Questions about this trial

What is this clinical trial studying?

A study testing Hemorrhoidal artery embolization in people with Internal Hemorrhoids and HAE, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Renato Escobar (310-956-6161, raescobar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score (time frame: From baseline to 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07179601, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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