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Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

NCT07264413 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Hemorrhoid
  • Hemorrhoid Bleeding

Interventions

PROCEDURE

Haemorrhoid artery embolizsation (HAE)

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Cook Group Incorporated

    collaborator INDUSTRY

  • Cardiovascular and Interventional Radiological Society of Europe

    lead OTHER

Principal Investigators

  • Clare Bent, Dr · Royal Bournemouth Hospital, University Hospitals Dorset NHS Foundation Trust

  • Christoph A. Binkert, Prof. Dr. med. · Medical Radiological Institute

  • Roberto Iezzi, Prof. · Fondazione Policlinico Agostino Gemelli, IRCCS Catholic University

  • Vincent Vidal, Prof. · Marseille University Hospital Timone

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2030-04-30
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264413 on ClinicalTrials.gov