Prospective HemorrhoIdaL EmboliSation (PILES) Registry

Part of paid clinical trials in Libertyville, Illinois.

Sponsor
Joint & Vascular Institute
Study ID
NCT07635784
Status
Recruiting
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Conditions

  • Hemorrhoid
  • Hemorrhoid Bleeding
  • Hemorrhoidal Bleeding
  • Internal Hemorrhoid
  • Internal Hemorrhoids

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hemorrhoid Artery Embolization — PROCEDURE
    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.

Study Details

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 knee osteoarthritis in adults aged 18 years or older with symptomatic bleeding internal hemorrhoids 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.

Key Dates

Start date
Jan 18, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
1,200 participants (estimated)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Joint and Vascular InstituteLibertyvilleIllinois60048
Layth Alkhani, BS
[email protected]
847-584-3959

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