Status:
WITHDRAWN
ARTerial EMbolization for haemorrhoIdal Disease (ART.EM.I. Study)
Lead Sponsor:
Oxford University Hospitals NHS Trust
Conditions:
Haemorrhoidal Bleeding
Eligibility:
All Genders
40-90 years
Phase:
NA
Brief Summary
Haemorrhoidal disease is amongst the most common rectal conditions causing significant distress to the affected patients. Current surgical techniques for the treatment of internal haemorrhoids are ass...
Detailed Description
This is a pilot, prospective, single arm and single centre trial to assess the safety and efficacy of haemorrhoid embolisation. Patients with advanced hemorrhoidal disease (grade II-IV) will be identi...
Eligibility Criteria
Inclusion
- i. Adult male and female patients between the ages of 40-90 years old.
- ii. Patients with grade II-IV haemorrhoid disease with re-current or active bleeding AND
- iii. Patients with (ii) who do not wish to undergo surgery for their symptoms OR
- iv. Patients with (ii) despite previous surgery.
- v. Patients who can understand and sign the consent form.
Exclusion
- i. Patients who are not otherwise fit for surgery.
- ii. Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses).
- iii. Patients who are unable to sign the inform consent form.
- iv. Pregnancy.
- v. Patients with history of significant colorectal disease or previous colectomy.
- vi. Iodine allergy/ Contrast allergy.
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04684251
Start Date
November 25 2020
End Date
May 24 2022
Last Update
August 18 2022
Active Locations (1)
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1
Department of Interventional Radiology, John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU