Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids

NCT ID: NCT06106269

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2026-12-31

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 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. Patients referred from the Colorectal Surgery Clinic who are scheduled to undergo rectal artery embolization (RAE) as part of standard clinical care will be enrolled. Baseline anoscopy and clinical evaluation will be performed per standard clinical care in the Colorectal Surgery Clinic and baseline patient reported outcomes and quality of life questionnaires administered. A research pelvis CTA will be performed on a clinical CT scanner per standard clinical imaging protocol for assessment of the rectal arteries prior to embolization. Following rectal artery embolization, subjects will undergo a day 1 post-procedure clinical evaluation in Interventional Radiology followed by repeat anoscopy and clinical evaluation per standard clinical care in the Colorectal Surgery Clinic as well as repeat patient reported outcomes and quality of life questionnaires at 1, 3, 6 and 12 months post rectal artery embolization with a clinical research study coordinator in Vascular and Interventional Radiology, either in person or virtually (video or phone).

The aims of the study are:

Aim 1. To determine the 12-month efficacy of rectal artery embolization with particles + coils for treatment of symptomatic bleeding predominant hemorrhoidal disease

Aim 2. To determine the 12-month safety of rectal artery embolization with particles + coils for treatment of symptomatic bleeding predominant hemorrhoidal disease.

Aim 3. To determine the feasibility of pre-embolization CTA in identifying the hemorrhoidal arteries supplying the hemorrhoidal cushion

Conditions

Internal Hemorrhoid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Rectal Artery Embolization

Subjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol.

Intervention Type: DEVICE

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Corporation

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Scott M. Thompson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Thompson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Vascular and Interventional Radiology

Scott R Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Colon and Rectal Surgery

Locations

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Desirae Howe-Clayton

Role: CONTACT

Howe.Desirae@mayo.edu

507-255-0111

Related Links

https://www.mayo.edu/research/clinical-trials/cls-20556753

Mayo Clinic Clinical Trials

Other Identifiers

23-002845

Identifier Type: -

Identifier Source: org_study_id