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NCT07264413
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Conditions: Hemorrhoid, Hemorrhoid Bleeding
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 250
Sponsor: Cardiovascular and Interventional Radiological Society of Europe
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.
Eligibility Criteria
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 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);
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.
Source: ClinicalTrials.gov (NCT07264413). StuddyBuddy aggregates publicly available trial information.