Hemorrhoidal BleedingSTRATOSNCT07559630
Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
A study testing Hemorrhoidal Artery Embolization and Rubber Band Ligation in people with Hemorrhoidal Bleeding and Hemorrhoids, Internal, run by Jessica K. Stewart, MD at 1 site in United States.
Trial summary
The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hemorrhoidal Bleeding, Hemorrhoids, Internal, HAE
- What is being tested?
- Hemorrhoidal Artery Embolization and Rubber Band Ligation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to Nov 2031
- Phase
- Interventional
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and less than 90 years.
- Ability to provide written informed consent.
- Documented clinical history of chronic bleeding from internal hemorrhoids.
- Documented presence of Goligher grade II-III internal hemorrhoids.
- Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
- Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's.
Who cannot join
- Moderate loss of kidney function, defined as estimated glomerular filtration rate of less than 45 mL/min.
- Significant arterial atherosclerosis that would limit selective angiography.
- Known alternative causes of GI bleeding.
- Allergy to iodinated contrast agents.
- Active infection or malignancy.
- Pregnancy.
Show all 10Show fewer
- Active nicotine use within the last 12 months.
- Portal hypertension/rectal varices.
- Uncorrectable coagulopathy (INR > 2; Platelet count <100,000; PTT > 40 sec).
- Findings on baseline CTA that adversely affect treatment, based on PI's clinical judgment, including but not limited to stenosis, occlusion, or hypoplasia of the superior and/or middle rectal arteries.
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
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Jessica Stewart, MD, 310-267-8769, JKStewart@mednet.ucla.edu
About this study
Official title: STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Directly comparing these two methods may help to clarify which treatment is better for controlling hemorrhoidal bleeding, reducing symptoms, and improving patients' quality of life.
HAE is a standard minimally invasive procedure to put tiny particles or coils into the blood vessel that feeds a hemorrhoid to block the blood flow (embolization). This involves using a catheter inserted into an artery, using twilight (conscious) sedation.
RBL is a standard procedure that involves using small rubber bands around the base of the hemorrhoids to cut off blood flow, causing it to shrink or shrivel.
Read the detailed description
A single center, prospective, open-label, double arm, randomized trial to compare rates of control of bleeding from hemorrhoids, during prospective follow-up in patients with internal hemorrhoids undergoing hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL), and the number of procedures needed for hemostasis.
Subjects will be considered enrolled in the study once they have provided informed consent. They will then be randomized to one of two arms after completion of the in-person screening visit. Subjects may proceed to the procedure visit after they have met all screening eligibility criteria.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will then be randomized to HAE or RBL in a 1:1 ratio. A total of 40 subjects will be enrolled in the study and followed for a duration of up to 18 months. All study subjects will undergo the initial procedures, consisting of a physical exam, vital signs, medical history, review of medications, laboratory blood evaluations, anascopy, and completion of completion of the hemorrhoidal disease symptom score (HDSS), the short health scale for hemorrhoidal disease (SHSHD), French bleeding score (FBS), and the visual analog scale (VAS) pain score questionnaires.
After treatment follow-up visits will be at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks) post-procedure. At these visits, subjects will complete all or some of the following: completion of the HDSS, SHSHD, FBS, VAS, and treatment satisfaction questionnaires, review current medications, undergo a directed physical examination, complete laboratory evaluations, anoscopy, CTA abdomen/ pelvis imaging, and report any new adverse events (AEs).
At 6 months, subjects will have the option to crossover because of continued bleeding. Subjects in the crossover group will undergo treatment with the other treatment modality, with follow up at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks).
- Conditions
- Hemorrhoidal Bleeding, Hemorrhoids, Internal, HAE, RBL
- Being tested
- Hemorrhoidal Artery Embolization, Rubber Band Ligation
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoidal Artery EmbolizationDevice
Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it.
Rubber Band LigationProcedure or surgery
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhoidal Artery Embolization | Active comparator | Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it. Receives: Device: Hemorrhoidal Artery Embolization |
| Rubber Band Ligation | Active comparator | Involves using a band to cut off blood flow to the hemorrhoid and shrink it. Receives: Procedure: Rubber Band Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedures to control bleeding
To compare rates of control of bleeding from hemorrhoids, based on number of procedures needed for hemostasis, during prospective follow-up in patients with internal hemorrhoids undergoing arterial embolization versus rubber band ligation.
Measured: 6 months
Secondary outcomes (5)
Complication rates
Number of complications post procedure for each complication type (such as severe pain, thrombosis, or severe bleeding).
Measured: 0-18 months
Time to control bleeding
Number of weeks to control bleeding post procedure
Measured: 0-18 months
Severe adverse events
Number of unscheduled ER visits or hospitalization for severe complications.
Measured: 0-18 months
Patient treatment satisfaction
Treatment satisfaction questionnaire
Measured: 0-18 months
Number of crossovers
Number of subjects who crossover from rubber band ligation to HAE, or vice versa at 6-months post procedure due to continued bleeding.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start19 May 2026
- Primary completionNov 2030 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoidal BleedingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A total of 40 subjects will be enrolled in the double-arm study, subjects will be randomized to HAE or RBL in a 1:1 ratio (20 assigned to HAE, 20 assigned to RBL). Subjects in the either arm will have the option to crossover to the other treatment modality if bleeding is not controlled by their 6-month follow-up time point. Subjects who crossover undergo the other treatment and undergo follow-up visits at \[1 week, 1 month, retreatment (if needed), 2 month, 3 month, 6 month, and 12 months\].
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica K. Stewart, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Sponsor-investigator, Jessica K. Stewart, MD, University of California, Los Angeles
- Investigators
- Jessica Stewart, MD, Principal investigator, University of California, Los AngelesDennis Jensen, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559630
- Sponsor's protocol ID
- 25-2437
- Acronym
- STRATOS
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Yan Z, Gui Y, Liu C, Zhang X, Wen C, Olatunji OJ, Suttikhana I, Ashaolu TJ. Gastrointestinal digestion of food proteins: Anticancer, antihypertensive, anti-obesity, and immunomodulatory mechanisms of the derived peptides. Food Res Int. 2024 Aug;189:114573. doi: 10.1016/j.foodres.2024.114573. Epub 2024 May 28.
PubMed 38876600Watanabe N, Hirose M, Hasegawa A, Mochida K, Ogura A, Inoue K. Derivation of embryonic stem cells from wild-derived mouse strains by nuclear transfer using peripheral blood cells. Sci Rep. 2023 Jul 10;13(1):11175. doi: 10.1038/s41598-023-38341-0.
PubMed 37430017Douek M. Radiofrequency Ablation of Solid, Non-Functional Thyroid Nodules. Tech Vasc Interv Radiol. 2022 Jun;25(2):100821. doi: 10.1016/j.tvir.2022.100821. Epub 2022 Mar 15. No abstract available.
PubMed 35551805Talaie R, Torkian P, Moghadam AD, Tradi F, Vidal V, Sapoval M, Golzarian J. Hemorrhoid embolization: A review of current evidences. Diagn Interv Imaging. 2022 Jan;103(1):3-11. doi: 10.1016/j.diii.2021.07.001. Epub 2021 Aug 27.
PubMed 34456172Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol. 2012 May 7;18(17):2009-17. doi: 10.3748/wjg.v18.i17.2009.
PubMed 22563187Panneau J, Mege D, Di Bisceglie M, Duclos J, Habert P, Bartoli A, Vidal V, Tradi F. Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques. Radiographics. 2022 Oct;42(6):1829-1844. doi: 10.1148/rg.220014.
PubMed 36190848Sandler RS, Peery AF. Rethinking What We Know About Hemorrhoids. Clin Gastroenterol Hepatol. 2019 Jan;17(1):8-15. doi: 10.1016/j.cgh.2018.03.020. Epub 2018 Mar 27.
PubMed 29601902Jutabha R, Jensen DM, Chavalitdhamrong D. Randomized prospective study of endoscopic rubber band ligation compared with bipolar coagulation for chronically bleeding internal hemorrhoids. Am J Gastroenterol. 2009 Aug;104(8):2057-64. doi: 10.1038/ajg.2009.292. Epub 2009 Jun 9.
PubMed 19513028
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
- ClinicalTrials.gov ID
- NCT07559630
- Acronym / sponsor ID
- STRATOS / 25-2437
- Conditions
- Hemorrhoidal Bleeding, Hemorrhoids, Internal, HAE, RBL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jessica K. Stewart, MDUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 19 May 2026 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 30 Apr 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.
The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Directly comparing these two methods may help to clarify which treatment is better for controlling hemorrhoidal bleeding, reducing symptoms, and improving patients' quality of life.
HAE is a standard minimally invasive procedure to put tiny particles or coils into the blood vessel that feeds a hemorrhoid to block the blood flow (embolization). This involves using a catheter inserted into an artery, using twilight (conscious) sedation.
RBL is a standard procedure that involves using small rubber bands around the base of the hemorrhoids to cut off blood flow, causing it to shrink or shrivel.
Detailed description
A single center, prospective, open-label, double arm, randomized trial to compare rates of control of bleeding from hemorrhoids, during prospective follow-up in patients with internal hemorrhoids undergoing hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL), and the number of procedures needed for hemostasis.
Subjects will be considered enrolled in the study once they have provided informed consent. They will then be randomized to one of two arms after completion of the in-person screening visit. Subjects may proceed to the procedure visit after they have met all screening eligibility criteria.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will then be randomized to HAE or RBL in a 1:1 ratio. A total of 40 subjects will be enrolled in the study and followed for a duration of up to 18 months. All study subjects will undergo the initial procedures, consisting of a physical exam, vital signs, medical history, review of medications, laboratory blood evaluations, anascopy, and completion of completion of the hemorrhoidal disease symptom score (HDSS), the short health scale for hemorrhoidal disease (SHSHD), French bleeding score (FBS), and the visual analog scale (VAS) pain score questionnaires.
After treatment follow-up visits will be at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks) post-procedure. At these visits, subjects will complete all or some of the following: completion of the HDSS, SHSHD, FBS, VAS, and treatment satisfaction questionnaires, review current medications, undergo a directed physical examination, complete laboratory evaluations, anoscopy, CTA abdomen/ pelvis imaging, and report any new adverse events (AEs).
At 6 months, subjects will have the option to crossover because of continued bleeding. Subjects in the crossover group will undergo treatment with the other treatment modality, with follow up at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 40 subjects will be enrolled in the double-arm study, subjects will be randomized to HAE or RBL in a 1:1 ratio (20 assigned to HAE, 20 assigned to RBL). Subjects in the either arm will have the option to crossover to the other treatment modality if bleeding is not controlled by their 6-month follow-up time point. Subjects who crossover undergo the other treatment and undergo follow-up visits at [1 week, 1 month, retreatment (if needed), 2 month, 3 month, 6 month, and 12 months].
| Arm | Type | Receives |
|---|---|---|
| Hemorrhoidal Artery Embolization | Active comparator | Device: Hemorrhoidal Artery EmbolizationInvolves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it. |
| Rubber Band Ligation | Active comparator | Procedure: Rubber Band LigationInvolves using a band to cut off blood flow to the hemorrhoid and shrink it. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and less than 90 years.
- Ability to provide written informed consent.
- Documented clinical history of chronic bleeding from internal hemorrhoids.
- Documented presence of Goligher grade II-III internal hemorrhoids.
- Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
Key exclusion criteria (10 listed)
- Moderate loss of kidney function, defined as estimated glomerular filtration rate of less than 45 mL/min.
- Significant arterial atherosclerosis that would limit selective angiography.
- Known alternative causes of GI bleeding.
- Allergy to iodinated contrast agents.
- Active infection or malignancy.
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 |
|---|---|---|
| Hemorrhoidal Artery EmbolizationInvolves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it. | Device | Hemorrhoidal Artery Embolization |
| Rubber Band LigationInvolves using a band to cut off blood flow to the hemorrhoid and shrink it. | Procedure or surgery | Rubber Band Ligation |
Primary outcome
Number of procedures to control bleeding
Time frame: 6 months
To compare rates of control of bleeding from hemorrhoids, based on number of procedures needed for hemostasis, during prospective follow-up in patients with internal hemorrhoids undergoing arterial embolization versus rubber band ligation.
5 secondary outcomes
Complication rates
Time frame: 0-18 months
Time to control bleeding
Time frame: 0-18 months
Severe adverse events
Time frame: 0-18 months
Patient treatment satisfaction
Time frame: 0-18 months
Number of crossovers
Time frame: 0-6 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 10 Jul 2026.
- Background: PubMed 38876600Yan Z, Gui Y, Liu C, Zhang X, Wen C, Olatunji OJ, Suttikhana I, Ashaolu TJ. Gastrointestinal digestion of food proteins: Anticancer, antihypertensive, anti-obesity, and immunomodulatory mechanisms of the derived peptides. Food Res Int. 2024 Aug;189:114573. doi: 10.1016/j.foodres.2024.114573. Epub 2024 May 28.
- Background: PubMed 37430017Watanabe N, Hirose M, Hasegawa A, Mochida K, Ogura A, Inoue K. Derivation of embryonic stem cells from wild-derived mouse strains by nuclear transfer using peripheral blood cells. Sci Rep. 2023 Jul 10;13(1):11175. doi: 10.1038/s41598-023-38341-0.
- Background: PubMed 35551805Douek M. Radiofrequency Ablation of Solid, Non-Functional Thyroid Nodules. Tech Vasc Interv Radiol. 2022 Jun;25(2):100821. doi: 10.1016/j.tvir.2022.100821. Epub 2022 Mar 15. No abstract available.
- Background: PubMed 34456172Talaie R, Torkian P, Moghadam AD, Tradi F, Vidal V, Sapoval M, Golzarian J. Hemorrhoid embolization: A review of current evidences. Diagn Interv Imaging. 2022 Jan;103(1):3-11. doi: 10.1016/j.diii.2021.07.001. Epub 2021 Aug 27.
- Background: PubMed 22563187Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol. 2012 May 7;18(17):2009-17. doi: 10.3748/wjg.v18.i17.2009.
- Background: PubMed 36190848Panneau J, Mege D, Di Bisceglie M, Duclos J, Habert P, Bartoli A, Vidal V, Tradi F. Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques. Radiographics. 2022 Oct;42(6):1829-1844. doi: 10.1148/rg.220014.
- Background: PubMed 29601902Sandler RS, Peery AF. Rethinking What We Know About Hemorrhoids. Clin Gastroenterol Hepatol. 2019 Jan;17(1):8-15. doi: 10.1016/j.cgh.2018.03.020. Epub 2018 Mar 27.
- Background: PubMed 19513028Jutabha R, Jensen DM, Chavalitdhamrong D. Randomized prospective study of endoscopic rubber band ligation compared with bipolar coagulation for chronically bleeding internal hemorrhoids. Am J Gastroenterol. 2009 Aug;104(8):2057-64. doi: 10.1038/ajg.2009.292. Epub 2009 Jun 9.
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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.
Jessica Stewart, MD principal investigator
University of California, Los Angeles
Dennis Jensen, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidal Artery Embolization and Rubber Band Ligation in people with Hemorrhoidal Bleeding and Hemorrhoids, Internal, run by Jessica K. Stewart, MD 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 10 Jul 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 Aniket Joglekar, MD (310-948-8026, ajoglekar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of procedures to control bleeding (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07559630, which also lists 8 linked publications.
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 10 Jul 2026.