RecruitingNCT06106269
Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids
Hemorrhoidal Embolization Trial-1 (HEMBO-1)
Sponsor
Mayo Clinic
Enrollment
20 participants
Start Date
Jun 7, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
Eligibility
Min Age: 18 YearsMax Age: 90 Years
Inclusion Criteria6
- 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 Criteria10
- Prior hemorrhoid surgery.
- Grade IV hemorrhoidal disease.
- Acute hemorrhoid complications.
- Chronic anal or perianal fissures.
- History of colorectal surgery or pelvic radiation.
- Inflammatory bowel disease.
- Portal hypertension or mesenteric venous congestion/occlusion.
- Inferior mesenteric artery (IMA) or internal iliac artery (IIA) stenosis or occlusion.
- Contraindication to iodinated contrast.
- Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure per clinical care.
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Interventions
DEVICERectal Artery Embolization
Subjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06106269