Clinical Trial

Prospective HemorrhoIdaL EmboliSation (PILES) Registry

Study acronym: PILES
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-04.
Trial Details
NCT Number NCT07635784
Lead Sponsor Joint & Vascular Institute
Conditions Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding, Hemorrhoidal Bleeding, Internal Hemorrhoid
Enrollment 1,200 participants
Start Date 2026-01-18
Primary Completion 2031-01 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-12