Internal HemorrhoidHEMBO-1NCT06106269
Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids
An observational study of Internal Hemorrhoid, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Internal Hemorrhoid
- What is being tested?
- Rectal Artery Embolization
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
Official title: Hemorrhoidal Embolization Trial-1 (HEMBO-1)
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
Read the 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
- Being tested
- Rectal Artery Embolization
- Keywords
- Bleeding, Anemia, Hemorrhoid
- Medical subject headings
- Hemorrhage, Anemia, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal Artery EmbolizationDevice
Subjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: Baseline (pre-embolization)
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: Baseline, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start7 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal HemorrhoidStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Corporation
- Responsible party
- Principal investigator, Scott M. Thompson, Mayo Clinic
- Investigators
- Scott Thompson, MD, PhD, Principal investigator, Mayo Clinic, Vascular and Interventional RadiologyScott R Kelley, MD, Principal investigator, Mayo Clinic, Colon and Rectal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106269
- Sponsor's protocol ID
- 23-002845
- Acronym
- HEMBO-1
- Status last verified
- Jun 2026
- First submitted
- 24 Oct 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidal Embolization Trial-1 (HEMBO-1)
- ClinicalTrials.gov ID
- NCT06106269
- Acronym / sponsor ID
- HEMBO-1 / 23-002845
- Conditions
- Internal Hemorrhoid
- Keywords
- Bleeding, Anemia, Hemorrhoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Terumo Corporation
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Prior hemorrhoid surgery.
- Grade IV hemorrhoidal disease.
- Acute hemorrhoid complications.
- Chronic anal or perianal fissures.
- History of colorectal surgery or pelvic radiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal Artery EmbolizationSubjects will undergo planned rectal artery embolization (RAE) in Vascular and Interventional Radiology per standard clinical protocol. | Device | – |
Primary outcome
Change in French bleeding score (FBS)
Time frame: Baseline, 1, 3, 6 and 12 months
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)
Adverse Events
Time frame: Day 1 and 1, 3, 6 and 12 months
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
Diagnostic accuracy of pre-embolization Computed Tomography Angiography (CTA)
Time frame: Baseline (pre-embolization)
Diagnostic accuracy and inter-rater agreement of pre-embolization CTA in identifying the hemorrhoidal arteries supplying the hemorrhoidal cushion
7 secondary outcomes
Visual Analog Scale (VSS) Pain
Time frame: Baseline, 1, 3, 6 and 12 months
Visual Analog Scale (VAS) for Quality of Life
Time frame: Baseline, 1, 3, 6 and 12 months
Goligher Prolapse Score
Time frame: Baseline, 1, 3, 6 and 12 months
Hemorrhoidal Bleeding Score (HBS)
Time frame: Baseline, 1, 3, 6 and 12 months
Hemorrhoidal Severity Score (HSS)
Time frame: Baseline, 1, 3, 6 and 12 months
Vaizey Incontinence Score
Time frame: Baseline, 1, 3, 6 and 12 months
Brief Pain Inventory (BPI) Short Form
Time frame: Baseline, 1, 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Thompson, MD, PhD principal investigator
Mayo Clinic, Vascular and Interventional Radiology
Scott R Kelley, MD principal investigator
Mayo Clinic, Colon and Rectal Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Hemorrhoid, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desirae Howe-Clayton (507-255-0111, Howe.Desirae@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in French bleeding score (FBS) (time frame: Baseline, 1, 3, 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.