RECRUITING

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

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Conditions

Internal HemorrhoidBleedingAnemiaHemorrhoid

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.

Official Title

Hemorrhoidal Embolization Trial-1 (HEMBO-1)

Quick Facts

Study Start:2024-06-07
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06106269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Grade II or III hemorrhoidal disease as determined by a board-certified colorectal surgeon.
  2. * Persistent or recurrent symptoms following hygiene and dietary measures or medication.
  3. * Bleeding predominant ± pain symptoms.
  4. * Undergoing planned rectal artery embolization (RAE) per standard clinical care.
  5. * Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent.
  6. * Negative pregnancy test (if applicable).
  1. * Prior hemorrhoid surgery.
  2. * Grade IV hemorrhoidal disease.
  3. * Acute hemorrhoid complications.
  4. * Chronic anal or perianal fissures.
  5. * History of colorectal surgery or pelvic radiation.
  6. * Inflammatory bowel disease.
  7. * Portal hypertension or mesenteric venous congestion/occlusion.
  8. * Inferior mesenteric artery (IMA) or internal iliac artery (IIA) stenosis or occlusion.
  9. * Contraindication to iodinated contrast.
  10. * Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure per clinical care.

Contacts and Locations

Study Contact

Desirae Howe-Clayton
CONTACT
507-255-0111
Howe.Desirae@mayo.edu

Principal Investigator

Scott Thompson, MD, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic, Vascular and Interventional Radiology
Scott R Kelley, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic, Colon and Rectal Surgery

Study Locations (Sites)

Mayo Clinic Minnesota
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Scott Thompson, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic, Vascular and Interventional Radiology
  • Scott R Kelley, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic, Colon and Rectal Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-06-07
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Bleeding
  • Anemia
  • Hemorrhoid

Additional Relevant MeSH Terms

  • Internal Hemorrhoid