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Recruiting
NCT07635784
Prospective HemorrhoIdaL EmboliSation (PILES) Registry
Conditions: Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding, Hemorrhoidal Bleeding, Internal Hemorrhoid
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1200
Sponsor: Joint & Vascular Institute
Location: Joint and Vascular Institute Libertyville Illinois
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 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.
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.
Source: ClinicalTrials.gov (NCT07635784). StuddyBuddy aggregates publicly available trial information.