Prospective HemorrhoIdaL EmboliSation (PILES) Registry

Creation Of a Prospective Registry For Hemorrhoid Artery Embolization At The Joint & Vascular Institute

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07635784

Acronym

PILES

Enrollment

1200

Registered

2026-06-09

Start date

2026-01-18

Completion date

2032-01-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoid, Hemorrhoidal Bleeding, Hemorrhoid Bleeding, Internal Hemorrhoid, Internal Hemorrhoids

Keywords

bleeding, hemorrhoids, internal hemorrhoids

Brief 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.

Interventions

PROCEDUREHemorrhoid 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Hemorrhoidal Disease Symptom Score (HDSS)	5 years of enrollment/patient

Secondary

Measure	Time frame
Short Health Scale for hemorrhoidal disease (SHSHD)	5 years of enrollment/patient
French Bleeding Score (FBS)	5 years of enrollment/patient

Countries

United States

Contacts

CONTACTLayth Alkhani, BS

lalkhani@jointvascular.com847-584-3959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026