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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

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
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

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 151 across 49 observational studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

Joint & Vascular Institute is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2031, 60 months after the start.

Of 27 observational studies under Hemorrhoids, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2026
First posted
Jun 9, 2026
StartActual
Jan 18, 2026
Primary completionEst.
Jan 2031
CompletionEst.
Jan 2032
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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Discussion (1)

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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