An observational study in Internal Hemorrhoid, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Mayo Clinic · Observational
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
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
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 20 is below the median of 215 across 397 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects referred from the Colon and Rectal Surgery who are scheduled to undergo rectal artery embolization (RAE) as part of their standard clinical care at the Mayo Clinic in Rochester, Minnesota.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol.
Change in French bleeding score (FBS)
The French bleeding score assesses the intensity of hemorrhoidal bleeding with scores ranging from 0 (no bleeding) to 9 (daily bleeding with anemia requiring blood transfusions)
Time frame: Baseline, 1, 3, 6 and 12 months
Adverse Events
Number of subjects to experience adverse events defined by 1) Common Terminology Criteria for Adverse Events (CTCAE) v6.0, 2) Society of Interventional Radiology \[SIR\] classifications of postoperative complications and 3) Clavien-Dindo Classification
Time frame: Day 1 and 1, 3, 6 and 12 months
Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)
Diagnostic accuracy and inter-rater agreement of pre-embolization CTA in identifying the hemorrhoidal arteries supplying the hemorrhoidal cushion
Time frame: Baseline (pre-embolization)
Visual Analog Scale (VSS) Pain
Pain values reported by participants will be assessed using a visual analogue scale with a line where each end is marked with "no pain" as 0 on the left, middle with "Moderate pain" as 5, and "worst possible pain" as 10 on the right. Participants will identify their pain level by indicating a point on the line between each end. Pain score 1-3 = mild pain, minimal impact on activities of daily living (ADL's); 4-6 = moderate pain, moderate impact on ADL's; 7-10 = severe pain, major impact on ADL's.
Time frame: Baseline, 1, 3, 6 and 12 months
Visual Analog Scale (VAS) for Quality of Life
The quality-of-life score evaluates disease impact with scores ranging from 0 (absence of discomfort) to 4 (permanent discomfort).
Time frame: Baseline, 1, 3, 6 and 12 months
Goligher Prolapse Score
The Goligher classification asses the degree of internal hemorrhoid prolapse from I (no prolapse) to IV (irreducible prolapse).
Time frame: Baseline, 1, 3, 6 and 12 months
Hemorrhoidal Bleeding Score (HBS)
HBS is sensitive, specific, and reproducible. It can assess the severity of hemorrhoidal bleeding. It also allows quantifying the extent of change in hemorrhoidal bleeding after treatment.
Time frame: Baseline, 1, 3, 6 and 12 months
Hemorrhoidal Severity Score (HSS)
The HSS comprises five items. All items included in a domain are scored between 0 and 3 (0 indicating best and 3 worst health status). A total score is obtained by summing the answers to each item. Lower scores indicate better haemorrhoidal health
Time frame: Baseline, 1, 3, 6 and 12 months
Vaizey Incontinence Score
The Vaizey incontinence score questionnaire is a seven-item measure in detecting fecal incontinence. The Vaizey consists of seven items, three of which ask about the frequency of incontinence on a 4-point scale ranging from 0 = Never to 4= Daily, followed by a single item about the extent to which symptoms alter lifestyle (using the same 4-point scale). The final three items are concerned with the severity of incontinence using a dichotomous No/Yes response scale (No=0, Yes=2 for items five and six, and 4 for item seven). The Vaizey score is calculated by summing responses across the seven items. A lower score indicates less fecal incontinence (e.g. 0=perfect continence, 24=totally incontinent).
Time frame: Baseline, 1, 3, 6 and 12 months
Brief Pain Inventory (BPI) Short Form
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
Time frame: Baseline, 1, 3, 6 and 12 months
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
Of 133 non-industry observational studies under Hemorrhage, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 78. This study's planned 30 months is below that.
Counting every sponsor, half of 157 studies reached it within 33 months; a quarter within 14 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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