Status:
RECRUITING
Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Terumo Corporation
Conditions:
Internal Hemorrhoid
Eligibility:
All Genders
18-90 years
Brief Summary
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
Detailed 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 intern...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06106269
Start Date
June 7 2024
End Date
December 1 2026
Last Update
June 12 2025
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905