Hemorrhoidal Artery Embolization for Hemorrhoids

(HELIOS Trial)

Overseen By Arshia Mian, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Colorectal surgery, Grade IV hemorrhoids, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 day

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called hemorrhoidal artery embolization (HAE) for individuals with troublesome internal hemorrhoids. The treatment reduces blood flow to the hemorrhoids by blocking certain blood vessels, potentially alleviating symptoms like bleeding. The study will evaluate the safety and effectiveness of HAE over a year, with check-ups at several intervals. Suitable candidates have had bleeding hemorrhoids confirmed by a doctor and are not interested in surgery or other common treatments. As an unphased trial, this study offers patients the chance to explore a novel treatment option that may relieve symptoms without surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hemorrhoidal artery embolization is safe for treating hemorrhoids?

Research has shown that hemorrhoidal artery embolization (HAE) safely treats internal hemorrhoids. Studies have found that HAE effectively reduces hemorrhoid symptoms, particularly bleeding. In one study, 93% of patients felt better just one month after the procedure. Another report highlights that HAE is minimally invasive, requiring no large incisions or extended recovery time. This makes it a suitable option, especially for those who haven't found relief from other treatments. Overall, patients have well-received HAE, and it offers a promising way to manage hemorrhoid symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hemorrhoidal artery embolization (HAE) is unique because it offers a minimally invasive alternative to traditional hemorrhoid treatments like rubber band ligation, sclerotherapy, and hemorrhoidectomy. Unlike these standard options, which often involve direct intervention at the site of the hemorrhoids, HAE works by blocking the blood flow to the hemorrhoidal arteries, reducing swelling and discomfort from the inside out. Researchers are excited about HAE because it has the potential to provide relief with less pain and a quicker recovery time, making it an attractive option for patients seeking a less invasive solution.

What evidence suggests that hemorrhoidal artery embolization is effective for hemorrhoids?

Research shows that hemorrhoidal artery embolization (HAE), the treatment under study in this trial, effectively treats bleeding hemorrhoids. Studies have found that it successfully reduces symptoms like bleeding and pain by cutting off blood flow to the affected areas. In clinical trials, HAE achieved technical success in 93-100% of cases and provided symptom relief in 63-94% of patients. This procedure is considered safe, with no serious complications reported. Overall, HAE offers a promising option for those seeking relief from internal hemorrhoids. ^{1 3 5 6 7}

Who Is on the Research Team?

Lucas Cusumano, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

The HELIOS trial is for adults aged 18-90 with symptomatic internal hemorrhoids, who have had an anoscopy or colonoscopy within the last year. Candidates must be experiencing significant bleeding and refuse or can't have surgery or other treatments. Smokers, those with severe bleeding disorders, previous colorectal surgeries, grade IV hemorrhoids, inflammatory bowel disease, active infections or cancer are excluded.

Inclusion Criteria

Ability to give written informed consent and to comply with the follow-up visits

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

Recent (within 12 months) or active cigarette use

Uncorrectable bleeding diathesis

No SRA or MRA supply to the CCR seen intra-procedural angiogram

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hemorrhoidal Artery Embolization

Trial Overview

This study tests Hemorrhoidal Artery Embolization (HAE), a new procedure that blocks blood flow to hemorrhoid tissue to reduce symptoms like bleeding. Participants will undergo HAE and attend follow-up visits at 1, 3, 6 and 12 months post-treatment to assess the long-term impact on their symptoms.

How Is the Trial Designed?

Group I: Hemorrhoidal artery embolization Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11572626/

Does hemorrhoidal artery embolization really benefit ...

Hemorrhoidal artery embolization (Emborrhoid) is an effective method of treating bleeding hemorrhoids, preserving anal function, and relieving pain.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07179601

Hemorrhoidal Artery Embolization: Longitudinal Impact On ...

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.

3.

journals.lww.com

journals.lww.com/ajg/fulltext/2025/10002/s1366_long_term_outcomes_of_hemorrhoidal_artery.1366.aspx

S1366 Long-Term Outcomes of Hemorrhoidal Artery...

Conclusion: HAE is a safe and effective outpatient treatment for internal hemorrhoids, demonstrating durable symptom relief regardless of prior RBL. These ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211568421001704

Hemorrhoid embolization: A review of current evidences

Current evidence shows that the Emborrhoid technique is safe for the treatment of hemorrhoids with no reported serious complications.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40877526/

Outcomes of embolization therapy of superior rectal ...

Technical success reached 93-100%. Clinical success ranged from 63 to 94%, yielding marked bleeding control and symptom relief. Reported ...

6.

jvir.org

jvir.org/article/S1051-0443(23)00112-4/abstract

Outcomes of Hemorrhoidal Artery Embolization from a ...

The mean number of SRA branches embolized per patient was 2.9 ± 1.0. Clinical success was seen in 93% (124 of 134) of patients at the 1-month follow-up, with ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1051044323001124

Outcomes of Hemorrhoidal Artery Embolization from a ...

The mean number of SRA branches embolized per patient was 2.9 ± 1.0. Clinical success was seen in 93% (124 of 134) of patients at the 1-month follow-up, with 10 ...