Recruiting

Hemorrhoid Artery Embolization

Sponsor:

Joint & Vascular Institute

Code:

NCT07635784

Conditions

Hemorrhoid

Internal Hemorrhoids

Hemorrhoid Bleeding

Hemorrhoidal Bleeding

Internal Hemorrhoid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hemorrhoid Artery Embolization

Study Details

Brief summary:

The goal of this observational study (prospective registry) is to collect long-term real-world data on the effectiveness and safety of hemorrhoid artery embolization (HAE) for symptomatic bleeding internal hemorrhoids in adults aged 18 years or older that have not responded to medical therapy.

The main question it aims to answer are:

1\) Does HAE lead to sustained improvement in bleeding (HDSS scores over 12-36 months?

Participants will:

  • Undergo HAE as part of their routine clinical care.
  • Complete clinical follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months after treatment, including symptom and quality-of-life questionnaires.
  • Have safety outcomes tracked according to Society of Interventional Radiology guidelines.

There is no comparison group; results will be analyzed to identify predictors of success and inform best practices for patient selection and treatment.

Conditions

Hemorrhoid

Internal Hemorrhoids

Hemorrhoid Bleeding

Hemorrhoidal Bleeding

Internal Hemorrhoid

Study ID

NCT07635784

Start date

Jan 18, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2032

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.

Exclusion Criteria:

  • Pregnancy, coagulopathy, severe comorbidities, or inability to consent.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Hemorrhoid Artery Embolization

Hemorrhoidal Artery Embolization (HAE)-often referred to clinically as the Emborrhoid technique-is a minimally invasive, image-guided procedure in which embolic agents are delivered into the superior rectal arteries to reduce hypervascular blood flow, thereby shrinking engorged hemorrhoidal plexuses and alleviating chronic bleeding and discomfort from internal hemorrhoids.

Primary outcome measure

  • Hemorrhoidal Disease Symptom Score (HDSS) [ Time Frame: 5 years of enrollment/patient ]

Central Contacts and Locations

Central contacts

Locations

Joint and Vascular Institute

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

More Information

Sponsor

Joint & Vascular Institute

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • bleeding
  • hemorrhoids
  • internal hemorrhoids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joint & Vascular Institute on 2026-06-12.