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RecruitingNCT07635784PILESUpdated Jun 12, 2026

Prospective HemorrhoIdaL EmboliSation (PILES) Registry

An observational study in Hemorrhoid, Internal Hemorrhoids and Hemorrhoid Bleeding, sponsored by Joint & Vascular Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Joint & Vascular Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemorrhoid
  • Internal Hemorrhoids
  • Hemorrhoid Bleeding
  • Hemorrhoidal Bleeding
  • Internal Hemorrhoid

Keywords

  • bleeding
  • hemorrhoids
  • internal hemorrhoids
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Inclusion criteria

  • Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

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.

05

What researchers measure

Primary outcomes

  1. Hemorrhoidal Disease Symptom Score (HDSS)

    Time frame: 5 years of enrollment/patient

Secondary outcomes

  1. Short Health Scale for hemorrhoidal disease (SHSHD)

    Time frame: 5 years of enrollment/patient

  2. French Bleeding Score (FBS)

    Time frame: 5 years of enrollment/patient

06

Study locations

1 of 1 sites recruiting
  • Joint and Vascular Institute
    Libertyville, Illinois 60048, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07635784
Lead sponsor
Joint & Vascular Institute
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Jan 18, 2026
Primary completion
Jan 2031 (estimated)
Completion
Jan 2032 (estimated)
Last update
Jun 12, 2026

Study contacts

Layth Alkhani, BS
Contact
lalkhani@jointvascular.com
847-584-3959

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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