Prospective HemorrhoIdaL EmboliSation (PILES) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemorrhoid Artery Embolization.
- Who it may be relevant to
- Registry conditions: Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding, Hemorrhoidal Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Creation Of a Prospective Registry For Hemorrhoid Artery Embolization At The Joint & Vascular Institute
Overview
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.
Interventions
- Procedure 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 measures
- Hemorrhoidal Disease Symptom Score (HDSS) [Time frame: 5 years of enrollment/patient]
Secondary outcome measures (2)
- Short Health Scale for hemorrhoidal disease (SHSHD) [Time frame: 5 years of enrollment/patient]
- French Bleeding Score (FBS) [Time frame: 5 years of enrollment/patient]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Joint and Vascular Institute — Libertyville
Identifiers
NCT: NCT07635784 · 1395380