Open Actively Recruiting

Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
90 Years

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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Study Stats
Protocol No.
25-0704
Category
GI Disorders
Principal Investigator
Contact
Arshia Mian
Location
  • UCLA North Hollywood
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT07179601
For detailed technical eligibility, visit ClinicalTrials.gov.