Recruiting

Rectal Artery Embolization

Sponsor:

Mayo Clinic

Code:

NCT06106269

Conditions

Internal Hemorrhoid

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rectal Artery Embolization

Study Details

Brief summary:

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

Conditions

Internal Hemorrhoid

Study ID

NCT06106269

Start date

Jun 7, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Rectal Artery Embolization

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

Primary outcome measure

  • Change in French bleeding score (FBS) [ Time Frame: Baseline, 1, 3, 6 and 12 months ]
  • Adverse Events [ Time Frame: Day 1 and 1, 3, 6 and 12 months ]
  • Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA) [ Time Frame: Baseline (pre-embolization) ]

Central Contacts and Locations

Central contacts

Desirae Howe-Clayton

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

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Bleeding
  • Anemia
  • Hemorrhoid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-17.