Actively Recruiting
Hemorrhoidal Embolization Trial-1 (HEMBO-1) to Evaluate Outcomes and Quality of Life in Patients Undergoing Rectal Artery Embolization for Bleeding Internal Hemorrhoids
Led by Mayo Clinic · Updated on 2025-06-12
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
T
Terumo Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how effective and safe rectal artery embolization is for treating symptomatic bleeding predominant internal hemorrhoids. It is a prospective, single-arm, single-center phase I/IIa observational study involving 20 adult patients with grade II or III bleeding predominant internal hemorrhoids referred for this procedure. The study is designed to systematically investigate patient outcomes and quality of life after treatment.
CONDITIONS
Brief Title
Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Grade II or III hemorrhoidal disease as determined by a board-certified colorectal surgeon
- Persistent or recurrent symptoms despite hygiene, dietary changes, or medication
- Bleeding predominant with or without pain symptoms
- Scheduled to undergo planned rectal artery embolization per standard care
- Male or female aged over 18 years able and willing to provide written informed consent
- Negative pregnancy test if applicable
You will not qualify if you...
- 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 or occlusion
- Inferior mesenteric artery or internal iliac artery stenosis or occlusion
- Contraindication to iodinated contrast
- Pregnant or breastfeeding women; negative pregnancy test required within 48 hours before procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo rectal artery embolization as part of standard clinical care.
1 procedure visit (in-person)
Duration - 12 months
Participants have clinical evaluations, repeat anoscopy, and complete patient reported outcomes and quality of life questionnaires to monitor recovery and outcomes.
6 visits: Day 1 post-procedure, and at 1, 3, 6, and 12 months (in-person or virtual)
Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
D
Desirae Howe-Clayton
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here