HemorrhoidPILESNCT07635784
Prospective HemorrhoIdaL EmboliSation (PILES) Registry
An observational study of Hemorrhoid and Internal Hemorrhoids, run by Joint & Vascular Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding
- What is being tested?
- Hemorrhoid Artery Embolization
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2026to Jan 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.
Who cannot join
- Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joint and Vascular Institute
Libertyville, Illinois, 60048
Layth Alkhani, BS, 847-584-3959, lalkhani@jointvascular.com
About this study
Official title: Creation Of a Prospective Registry For Hemorrhoid Artery Embolization At The Joint & Vascular Institute
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:
Read more
- 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.
- Conditions
- Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding, Hemorrhoidal Bleeding, Internal Hemorrhoid
- Being tested
- Hemorrhoid Artery Embolization
- Keywords
- bleeding, hemorrhoids, internal hemorrhoids
- Medical subject headings
- Hemorrhoids, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoid Artery EmbolizationProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhoidal Disease Symptom Score (HDSS)
Measured: 5 years of enrollment/patient
Secondary outcomes (2)
Short Health Scale for hemorrhoidal disease (SHSHD)
Measured: 5 years of enrollment/patient
French Bleeding Score (FBS)
Measured: 5 years of enrollment/patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start18 Jan 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Joint & Vascular Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635784
- Sponsor's protocol ID
- 1395380
- Acronym
- PILES
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation Of a Prospective Registry For Hemorrhoid Artery Embolization At The Joint & Vascular Institute
- ClinicalTrials.gov ID
- NCT07635784
- Acronym / sponsor ID
- PILES / 1395380
- Conditions
- Hemorrhoid, Internal Hemorrhoids, Hemorrhoid Bleeding, Hemorrhoidal Bleeding, Internal Hemorrhoid
- Keywords
- bleeding, hemorrhoids, internal hemorrhoids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Joint & Vascular InstituteIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults (≥18 years) with symptomatic bleeding internal hemorrhoids refractory to medical therapy, referred for HAE.
Key exclusion criteria (1 listed)
- Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemorrhoid Artery EmbolizationHemorrhoidal 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. | Procedure or surgery | – |
Primary outcome
Hemorrhoidal Disease Symptom Score (HDSS)
Time frame: 5 years of enrollment/patient
2 secondary outcomes
Short Health Scale for hemorrhoidal disease (SHSHD)
Time frame: 5 years of enrollment/patient
French Bleeding Score (FBS)
Time frame: 5 years of enrollment/patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoid and Internal Hemorrhoids, run by Joint & Vascular Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layth Alkhani, BS (847-584-3959, lalkhani@jointvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhoidal Disease Symptom Score (HDSS) (time frame: 5 years of enrollment/patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.