Hemorrhoidal Embolization Trial-1 (HEMBO-1)
Mayo Clinic
Summary
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
Description
This is a prospective, single-arm, single center phase I/IIa observational study to systematically investigate outcomes and quality of life in patients with grade II or III bleeding predominant internal hemorrhoids referred to Vascular and Interventional Radiology (VIR) by Colorectal Surgery (CRS) for clinically indicated rectal artery embolization. 20 adult patients who meet the inclusion and exclusion criteria will be consented and enrolled in the study. During the study, the subject will undergo 6 study visits, one before and five after their clinical rectal artery embolization procedure.…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Grade II or III hemorrhoidal disease as determined by a board-certified colorectal surgeon. * Persistent or recurrent symptoms following hygiene and dietary measures or medication. * Bleeding predominant ± pain symptoms. * Undergoing planned rectal artery embolization (RAE) per standard clinical care. * Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent. * Negative pregnancy test (if applicable). Exclusion Criteria: * Prior hemorrhoid surgery. * Grade IV hemorrhoidal disease. * Acute hemorrhoid complic…
Interventions
- DeviceRectal Artery Embolization
Subjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol.
Location
- Mayo Clinic MinnesotaRochester, Minnesota