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New coil treatment could replace surgery for bleeding hemorrhoids

NCT ID NCT07264413

Disease control Sponsor: Cardiovascular and Interventional Radiological Society of Europe Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

The BRIGHT study will follow 250 adults with grade II-III hemorrhoids who are treated with a procedure called hemorrhoid artery embolization (HAE). This technique uses tiny metal coils to block blood flow to the hemorrhoids, aiming to stop bleeding without major surgery. Researchers will track how well it works in everyday practice across Europe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
haemorrhoid artery embolization (HAE) with embolization coils
What this could lead to
If it works, this could offer a less painful, faster-recovery alternative to surgery for people with bleeding hemorrhoids.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The procedure may not work for everyone, and risks like infection or coil migration exist.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with bleeding grade II-III haemorrhoids (French Bleeding Score ≥3) planned to be treated with HAE coil-only embolization who fit the eligibility criteria

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult patients presenting bleeding Grade II-III haemorrhoids with French bleeding score ≥3 planned to be treated with HAE using embolization coils; 2. Patients competent and willing to give written informed consent. Exclusion Criteria: 1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.); 2. Patients receiving HAE using a combination of coils and particles, particles only, or any other embolic agents; 3. Patients who have had previous surgical haemorrhoidectomy at any time or other treatments for haemorrhoids within 1 year before the planned HAE; 4. Patients with known perianal sepsis, inflammatory bowel disease, peri-anal fistula, colorectal malignancy or pre-existing sphincter injury resulting in incontinence; 5. Patients with an immunodeficiency; 6. Known severe atheromatous disease with occlusion of target vessels preventing embolization; 7. Absolute contraindication to contrast media; 8. ECOG performance status \> 2; 9. Life expectancy \< 12 months; 10. Patients with unstable angina; 11. Patients currently taking nicorandil.

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Conditions

The condition(s) this trial relates to.

hemorrhoid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhoid Hemorrhoid bleeding

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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