Hemorrhoidal Artery Embolization for Hemorrhoids
(HELIOS Trial)
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.12345
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.13567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hemorrhoidal Artery Embolization
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor