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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of adult patients (18 years and older) presenting to the Joint \& Vascular Institute for clinical consultation regarding symptomatic internal hemorrhoids. This population includes individuals who have failed standard medical management (such as dietary modifications, topical therapies, or office-based procedures) and are seeking minimally invasive alternatives to surgical hemorrhoidectomy. The registry will include men and women of all races and ethnicities without exclusion, provided they meet the clinical criteria for Hemorrhoidal Artery Embolization (HAE) as determined by the Principal Investigator or Sub-Investigators.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hemorrhoid Artery Embolization
Procedure/SurgeryHemorrhoidal 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Hemorrhoidal Disease Symptom Score (HDSS)
Time frame
5 years of enrollment/patientSecondary outcomes
1
Short Health Scale for hemorrhoidal disease (SHSHD)
Time frame
5 years of enrollment/patient2
French Bleeding Score (FBS)
Time frame
5 years of enrollment/patientSponsors and contacts
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Source ClinicalTrials.gov