Hemorrhoids InternalPhase 2HemEmboNCT07844629
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
A Phase 2 study testing Rectal Artery Embolization and Operative Hemorrhoidectomy in people with Hemorrhoids Internal and Hemorrhoids Second Degree, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids Internal, Hemorrhoids Second Degree, Hemorrhoids Third Degree
- What is being tested?
- Rectal Artery Embolization and Operative Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to 19 Oct 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged >18 years
- Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
- French bleeding score > 5
- Rectal bleeding greater than 3 months
- Colonoscopy within three years, negative for colorectal malignancy
- INR < 1.5
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- Platelet count > 150,000/dL
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after intervention
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Current use of anticoagulants and/or DAPT
- Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
- Prior surgical or endovascular treatment of hemorrhoids
- Prior endoscopic hemorrhoid artery ligation
- Pregnancy or lactation
- Known severe allergic reactions to iodinated contrast not mitigated by standard prophylaxis
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- Bleeding attributable to other anorectal pathology such as anal fissures, anorectal abscess, or fistula
- Inflammatory bowel disease
- Inflammatory vasculitis or connective tissue disease
- Current participation in another clinical trial which may interfere with participation in this study
- Treatment with bevacizumab within 2 months
- Contraindication to surgical management of internal hemorrhoids
- Primary or secondary malignancy involving the abdomen or pelvis which is likely to impact treatment
- Prior pelvic radiation therapy
- Prior diagnosis of portal hypertension
- Major comorbidities expected to impact outcomes or increase patient risk, in the judgement of the enrolling physician
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
University of Colorado Health
Aurora, Colorado, 80045
Alejandra Aguilar, MPH, CCRP, CPH, 7208486612, alejandra.aguilar@cuanschutz.edu
Jonathan Lindquist, MD
About this study
Official title: Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.
The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.
A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.
- Being tested
- Rectal Artery Embolization, Operative Hemorrhoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal Artery EmbolizationProcedure or surgery
A minimally invasive procedure in which a doctor uses imaging guidance to place a small catheter into an artery and injects embolization materials to block the blood vessels supplying the hemorrhoids. This reduces blood flow and helps shrink the hemorrhoids.
Operative HemorrhoidectomyProcedure or surgery
A surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Artery Embolization | Experimental | Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. Receives: Procedure: Rectal Artery Embolization |
| Operative Hemorrhoidectomy | Active comparator | Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. Receives: Procedure: Operative Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Following Treatment
Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life.
Measured: Baseline and 1 month after treatment
Secondary outcomes (4)
Time to Return to Work
Comparison of time to return to work following superior rectal artery embolization and open surgical hemorrhoidectomy.
Measured: From treatment through return to work or normal activities, up to 6 months after treatment
Time to Return to Pre-Intervention Activities
Comparison of time to return to pre-intervention activities following superior rectal artery embolization and open surgical hemorrhoidectomy as measured by selected elements of the adapted VEINES questionnaire. Scores range from 3 to 12, with higher scores indicating less limitation in daily, social, and leisure activities and therefore better functional recovery. Lower scores indicate greater activity limitation and poorer functional recovery.
Measured: From treatment until return to pre-intervention activities, up to 6 months after treatment
Achievement of French Bleeding Score <2
Comparison of proportion of patients that achieve French Bleeding Scores < 2 following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids. For the French Bleeding Score, total scores range from 0 to 9, with lower scores indicating less bleeding and better clinical outcomes, and higher scores indicating more severe hemorrhoidal bleeding and worse clinical outcomes.
Measured: 6 months after treatment
Treatment-Related Adverse Events
Comparison of adverse events following superior rectal artery embolization and open surgical hemorrhoidectomy for the treatment of bleeding Goligher Grade 2 and 3 internal hemorrhoids.
Measured: From treatment through 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion19 Oct 2028 (estimated)
- Study completion19 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoids InternalStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with symptomatic bleeding Goligher grade 2 or 3 internal hemorrhoids will be randomly assigned in a 1:1 ratio to undergo either rectal artery embolization or operative hemorrhoidectomy. The two treatment groups will be followed in parallel and compared with respect to quality of life, return to work and normal activities, bleeding outcomes, and treatment-related adverse events.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844629
- Sponsor's protocol ID
- 25-0192
- Acronym
- HemEmbo
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
- ClinicalTrials.gov ID
- NCT07844629
- Acronym / sponsor ID
- HemEmbo / 25-0192
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 19 Oct 2028 (estimated)
- Study completion
- 19 Oct 2028 (estimated)
- First posted
- 28 Sep 2026 (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 Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.
The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.
A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with symptomatic bleeding Goligher grade 2 or 3 internal hemorrhoids will be randomly assigned in a 1:1 ratio to undergo either rectal artery embolization or operative hemorrhoidectomy. The two treatment groups will be followed in parallel and compared with respect to quality of life, return to work and normal activities, bleeding outcomes, and treatment-related adverse events.
| Arm | Type | Receives |
|---|---|---|
| Rectal Artery Embolization | Experimental | Procedure: Rectal Artery EmbolizationParticipants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
| Operative Hemorrhoidectomy | Active comparator | Procedure: Operative HemorrhoidectomyParticipants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged >18 years
- Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
- French bleeding score > 5
- Rectal bleeding greater than 3 months
- Colonoscopy within three years, negative for colorectal malignancy
Key exclusion criteria (16 listed)
- Current use of anticoagulants and/or DAPT
- Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
- Prior surgical or endovascular treatment of hemorrhoids
- Prior endoscopic hemorrhoid artery ligation
- Pregnancy or lactation
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 EmbolizationA minimally invasive procedure in which a doctor uses imaging guidance to place a small catheter into an artery and injects embolization materials to block the blood vessels supplying the hemorrhoids. This reduces blood flow and helps shrink the hemorrhoids. | Procedure or surgery | Rectal Artery Embolization |
| Operative HemorrhoidectomyA surgical procedure performed under anesthesia in which the surgeon removes or excises the hemorrhoidal tissue. This is the current standard treatment for severe hemorrhoids. | Procedure or surgery | Operative Hemorrhoidectomy |
Primary outcome
Quality of Life Following Treatment
Time frame: Baseline and 1 month after treatment
Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life.
4 secondary outcomes
Time to Return to Work
Time frame: From treatment through return to work or normal activities, up to 6 months after treatment
Time to Return to Pre-Intervention Activities
Time frame: From treatment until return to pre-intervention activities, up to 6 months after treatment
Achievement of French Bleeding Score <2
Time frame: 6 months after treatment
Treatment-Related Adverse Events
Time frame: From treatment through 6 months after treatment
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 28 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rectal Artery Embolization and Operative Hemorrhoidectomy in people with Hemorrhoids Internal and Hemorrhoids Second Degree, run by University of Colorado, Denver 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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 28 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Following Treatment (time frame: Baseline and 1 month after treatment). 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 28 Sep 2026.