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NCT Number: NCT07264413

Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

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.

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Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoid Bleeding Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 surgical haemorrhoidectomy at any time or other treatments for haemorrhoids within 1 year before the planned HAE;
  • 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;
  • Absolute contraindication to contrast media;
  • ECOG performance status > 2;
  • Life expectancy < 12 months;
  • Patients with unstable angina;
  • Patients currently taking nicorandil.

Treatment and study plan

Haemorrhoid artery embolizsation (HAE)

Procedure

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.

Other names: Embolization Coils

Primary outcomes

  1. Haemorrhoidal bleeding

    Time frame: 12 months

    Evaluated using the French Bleeding Score.

Secondary outcomes

  1. Haemorrhoidal bleeding

    Time frame: 1, 3 and 24 months

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

  2. Patient-reported Pain using the Visual Analogue Scale

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

    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.

  3. Patient-reported Pain measured by Analgesic intake

    Time frame: 1 day, 1- and 3-months post treatment

    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.

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

    Time frame: Within 3 months after the HAE procedure

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

  5. Functional recovery

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

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

  6. Freedom from recurrence

    Time frame: 1, 3, 12 and 24 months

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

  7. Clinical appearance of haemorrhoids

    Time frame: 12 months

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

  8. Patient-reported symptoms

    Time frame: 3, 12 and 24 months

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

  9. Patient-reported continence

    Time frame: 3 months

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

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

    Time frame: 1 day, 1-, 3-, 12- and 24-months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Poulet, PhD

CONTACT

[email protected]

+41 79 385 16 78

Dhwani S. Korde, PhD

CONTACT

[email protected]

+4367762942469

Sponsors and collaborators

Lead sponsor

Cardiovascular and Interventional Radiological Society of Europe

Other

Collaborators

  • Cook Group Incorporated
  • Medtronic

Registry information

Acronym: BRIGHT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 4, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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