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HemorrhoidBRIGHTNCT07264413

Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

An observational study of Hemorrhoid and Hemorrhoid Bleeding, run by Cardiovascular and Interventional Radiological Society of Europe.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

BRIGHT is a Europe-wide study that will follow up to 250 adults with bleeding symptoms from haemmorhoids (Grade II-III categories). It aims to understand how well a minimally invasive procedure called haemorrhoid artery embolization (HAE) works in everyday clinical practice, which is a technique that blocks the blood… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhoid, Hemorrhoid Bleeding
What is being tested?
Haemorrhoid artery embolizsation (HAE)
Type of treatment
Surgery or procedure
How many people
250 participants
Where
No sites listed yet
Study dates
Nov 2026to Dec 2030
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: 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

Who may be able to join

  • Adult patients presenting bleeding Grade II-III haemorrhoids with French bleeding score ≥3 planned to be treated with HAE using embolization coils;
  • Patients competent and willing to give written informed consent.

Who cannot join

  • 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.);
  • Patients receiving HAE using a combination of coils and particles, particles only, or any other embolic agents;
  • Patients who have had previous HAE or surgical haemorrhoidectomy at any time or other treatments for haemorrhoids within 1 year before the planned HAE (rubber band ligation and infra-red therapy allowed);
  • Patients with known perianal sepsis, inflammatory bowel disease, peri-anal fistula, colorectal malignancy or pre-existing sphincter injury resulting in incontinence;
  • Patients with an immunodeficiency;
  • Known severe atheromatous disease with occlusion of target vessels preventing embolization;
Show all 11Show fewer
  • Absolute contraindication to contrast media;
  • ECOG performance status > 2;
  • Life expectancy < 12 months;
  • Patients with unstable angina;
  • Patients currently taking nicorandil.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Claire Poulet, PhD contact

+41 79 385 16 78

bright@cirse.org

Dhwani S. Korde, PhD contact

+4367762942469

bright@cirse.org

About this study

BRIGHT is a Europe-wide study that will follow up to 250 adults with bleeding symptoms from haemmorhoids (Grade II-III categories). It aims to understand how well a minimally invasive procedure called haemorrhoid artery embolization (HAE) works in everyday clinical practice, which is a technique that blocks the blood vessels feeding the haemorrhoids. As this technique does not require major surgery, HAE offers several benefits such as less trauma, quicker recovery, and the use of only local anaesthesia.

Being tested
Haemorrhoid artery embolizsation (HAE)
Keywords
Haemorrhoids, Grade II-III haemorrhoids, Symptomatic haemorrhoids, Hemorrhoidal bleeding, Haemorrhoidal disease, Haemorrhoid artery embolization, HAE, Artery embolization, Transarterial embolization, Minimally invasive, Embolization coils
Medical subject headings
Hemorrhoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Haemorrhoid artery embolizsation (HAE)Procedure or surgery

    Also called Embolization Coils

    Haemorrhoid artery embolization (HAE) is a minimally invasive procedure used to treat symptomatic haemorrhoids by reducing their blood supply. Under imaging guidance, typically fluoroscopy, a catheter is inserted through a small puncture in the groin or wrist and guided into the arteries that supply the haemorrhoidal tissue, known as the superior rectal arteries.

    Once the target vessels are identified, embolization coils-tiny metal coils designed to block blood flow-are placed inside these arteries. The coils create a controlled blockage, decreasing blood flow to the haemorrhoids, which helps shrink the swollen tissue and reduce bleeding.

    HAE is usually performed as an day-case procedure under local anaesthesia with mild sedation, and tends to result in less pain, quicker recovery, and lower complication rates compared to surgical approaches.

Study groups in NCT07264413
Study groupRoleWhat they receive
Adult patients with bleeding grade II-III haemorrhoidsAdult patients with bleeding grade II-III haemorrhoids planned to be treated with Haemorrhoid artery embolization (HAE) using embolization coils
Receives: Procedure: Haemorrhoid artery embolizsation (HAE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Haemorrhoidal bleeding

    Evaluated using the French Bleeding Score.

    Measured: 12 months

Secondary outcomes (10)

  1. Haemorrhoidal bleeding

    Evaluation of haemorrhoidal bleeding at time points listed below compared to baseline using the French Bleeding Score.

    Measured: 1, 3 and 24 months

  2. Patient-reported Pain using the Visual Analogue Scale

    The 10 cm Visual Analogue Scale (VAS) is a patient-reported outcome measure used to assess the intensity of a symptom such as pain, discomfort, or bleeding. It consists of a straight, 10-centimeter horizontal line with two anchored endpoints: 0 cm = no symptom, and 10 cm = worst imaginable symptom. Participants mark a point on the line that best represents the severity of their symptom at the time of assessment. This will be measured at 1 day, 1- and 3-months after the treatment.

    Measured: 1 day, 1- and 3-months post treatment, compared to baseline

  3. Patient-reported Pain measured by Analgesic intake

    Analgesic intake refers to the use of any pain-relief medication taken to manage haemorrhoid-related discomfort after HAE. This includes over-the-counter or prescribed agents such as acetaminophen/paracetamol or NSAIDs. Participants will be recorded as having taken analgesics if they use any pain medication for haemorrhoid symptoms during the specified time frame.

    Measured: 1 day, 1- and 3-months post treatment

  4. Frequency and severity of procedural complications and other adverse events

    The severity of complications and procedure-related adverse events will be graded according to the Clavian Dindo classification system.

    Measured: Within 3 months after the HAE procedure

  5. Functional recovery

    Measured as the number of days until the patient is fit enough to return to work or other usual daily activities.

    Measured: From the procedure date until the patient returns to work or usual daily activities (Number of days)

  6. Freedom from recurrence

    Defined as the proportion of patients with cured or improved symptoms as described in the HubBle Trial.

    Measured: 1, 3, 12 and 24 months

  7. Clinical appearance of haemorrhoids

    Evaluated at proctoscopy at 12 months if done per SOC or following recurrence requiring further intervention.

    Measured: 12 months

  8. Patient-reported symptoms

    Evaluated using the Haemorrhoids Severity Score at the specified time points below compared to baseline.

    Measured: 3, 12 and 24 months

  9. Patient-reported continence

    Assessed using the Vaizey Incontinence Score at the specified time points below compared to baseline.

    Measured: 3 months

  10. Patient-reported health-related quality-of-life

    Measured by EuroQol Five-Dimension, Five-Level Questionnaire (EuroQol EQ-5D-5L) at the specified time points below compared to baseline. It is a standardized, participant-reported measure of health-related quality of life that assesses five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to perform. Higher EQ-5D-5L index values indicate better overall health status, while lower scores reflect poorer health, greater symptom burden, or more functional impairment.

    Measured: 1 day, 1-, 3-, 12- and 24-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07264413
Sponsor's protocol ID
BRIGHT
Acronym
BRIGHT
Status last verified
Oct 2026
First submitted
20 Nov 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.

    PubMed 27236344

  • Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.

    PubMed 9862829

  • Nystrom PO, Qvist N, Raahave D, Lindsey I, Mortensen N; Stapled or Open Pile Procedure (STOPP) trial study group. Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse. Br J Surg. 2010 Feb;97(2):167-76. doi: 10.1002/bjs.6804.

    PubMed 20035531

  • Fathallah N, Beaussier H, Chatellier G, Meyer J, Sapoval M, Moussa N, de Parades V. Proposal for a New Score: Hemorrhoidal Bleeding Score. Ann Coloproctol. 2021 Oct;37(5):311-317. doi: 10.3393/ac.2020.08.19. Epub 2020 Sep 18.

    PubMed 32972102

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhoid and Hemorrhoid Bleeding, run by Cardiovascular and Interventional Radiological Society of Europe.

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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Claire Poulet, PhD (+41 79 385 16 78, bright@cirse.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Haemorrhoidal bleeding (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07264413, which also lists 5 linked publications.

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 21 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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