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Clinical Trials/NCT07264413
NCT07264413
Not yet recruiting
Not Applicable

Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

Cardiovascular and Interventional Radiological Society of Europe0 sites250 target enrollmentStarted: April 1, 2026Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Cardiovascular and Interventional Radiological Society of Europe
Enrollment
250
Primary Endpoint
Haemorrhoidal bleeding
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief 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 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Outcomes

Primary Outcomes

Haemorrhoidal bleeding

Time Frame: 12 months

Evaluated using the French Bleeding Score.

Secondary Outcomes

  • Haemorrhoidal bleeding(1, 3 and 24 months)
  • Patient-reported Pain using the Visual Analogue Scale(1 day, 1- and 3-months post treatment, compared to baseline)
  • Patient-reported Pain measured by Analgesic intake(1 day, 1- and 3-months post treatment)
  • Frequency and severity of procedural complications and other adverse events(Within 3 months after the HAE procedure)
  • Functional recovery(From the procedure date until the patient returns to work or usual daily activities (Number of days))
  • Freedom from recurrence(1, 3, 12 and 24 months)
  • Clinical appearance of haemorrhoids(12 months)
  • Patient-reported symptoms(3, 12 and 24 months)
  • Patient-reported continence(3 months)
  • Patient-reported health-related quality-of-life(1 day, 1-, 3-, 12- and 24-months)

Investigators

Sponsor
Cardiovascular and Interventional Radiological Society of Europe
Sponsor Class
Other
Responsible Party
Sponsor

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