Prospective HemorrhoIdaL EmboliSation (PILES) Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJoint & Vascular Institute
About this trial
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.
Eligibility criteria
Qualifiers
Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.
Disqualifiers
Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
Trial design
Treatments tested in this trial
- Hemorrhoid Artery Embolization
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov