Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
NCT07179601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-02-02
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.
Conditions
- Internal Hemorrhoids
- HAE
Interventions
- PROCEDURE
-
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.
Sponsors & Collaborators
-
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Lucas Cusumano, MD · University of California, Los Angeles
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-05
- Primary Completion
- 2028-09-30
- Completion
- 2029-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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