Morbid ObesityEmbargoNCT04207424
Embolization of Arterial Gastric Supply in Obesity
A study testing Emblization of the gastro-epiploic arcade in people with Morbid Obesity, run by IHU Strasbourg.
Trial summary
This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Emblization of the gastro-epiploic arcade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2020to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient aged ≥18 and ≤ 71 years old
- BMI ≥ 40 or BMI ≥ 35 in association with one of the following comorbidities: hypertension, type 2 diabetes, obstructive sleep apnea
- Relative contraindication to bariatric surgery
- Able to sign informed consent.
Who cannot join
- General
- Impossible or unwilling to attend follow-up visits.
- Weight > 250kg (weight limit of angiography table)
- Confirmed allergy to intravenous contrast agents.
- Pregnancy, breast feeding or willingness to conceive during the following year
- Impossible to maintain dorsal decubitus during intervention
Show all 41Show fewer
- Life expectancy < 1 year
- Current enrollment in another clinical trial
- Arterial anatomy rendering embolization very difficult or impossible (as evaluated by investigators)
- Patient under the protection of justice
- Patient under guardianship or trusteeship
- Gastro-intestinal
- Pre-existing chronic abdominal pain
- History of inflammatory bowel disease
- History of gastroparesis
- History of gastric surgery, gastric embolization or radiotherapy
- History of peptic ulcer
- Significant risk factors for peptic ulcer, including daily use of non-steroidal anti-inflammatory drugs, active smoking or active infection with Helicobacter pylori
- Abnormal upper digestive endoscopy
- Hepatic
- Cirrhosis
- Portal venous hypertension
- Bilirubin > 2,0 mg/dL
- Albumin < 2,5 g/L
- Cardiovascular
- Known aortic pathology i.e. aneurysm or dissection
- Severe peripheral arterial disease
- Renal
- Renal failure, Creatinine Clearance < 60ml/min/1,73 m2
- Hematologic/Immunologic/Oncologic/Infectious
- Acute or chronic infection
- Active cancer
- Auto-immune disease requiring immunosuppression
- Neutrophil count < 1,5 x 10 ^ 9/L
- Platelet count < 100 x 10 ^ 9/L
- Contraindication to contrast medium Visipaque solution for injection
- Hypersensitivity to the active substance (Iodixanol) or to any of the excipients
- History of immediate major or delayed skin reaction to the injection of the product
- Decompensated heart failure
- Thyrotoxicosis
- Contraindication to the use of the embogold microsphere
About this study
Official title: EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses
This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
Read the detailed description
Obesity is now an epidemic in the developed and developing world. Medical management is ineffective at population level. Metabolic surgery has been shown to be effective in achieving weight loss and controlling associated conditions. However, surgery is invasive and has associated complications. Furthermore, not every patient is interested in or eligible for surgery.
Bariatric gastric embolization recently emerged as a promising minimally invasive alternative to open bariatric surgery. Data from several initial pilot clinical trials suggests that gastric embolization is safe and can induce weight loss.
Previous studies have concentrated on left gastric artery embolization as the primary target vessel because it supplies the largest portion of the fundus. However, it may be desirable to target a different artery, specifically the left gastroepiploic which also supplies the fundus. The left gastric artery is spared in bariatric surgery because it supplies the residual pouch after the surgery. Embolization of the left gastric artery may result in worse healing in the event of follow-up surgery potentially excluding people should they subsequently want it or become eligible.
This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
The target population consists of adult, morbidly obese patients with contraindication for bariatric surgery. Patients included in the study will be followed up for 12 months post bariatric embolization. The primary end point is procedural safety, defined as number and severity of adverse events occurring during the study period. Secondary end points include weight loss, evolution of weight and thigh circumferences, evolution of serum ghrelin levels and evolution of quality of life indexes.
- Conditions
- Morbid Obesity
- Being tested
- Emblization of the gastro-epiploic arcade
- Keywords
- Bariatric embolization, Obesity, Metabolic syndrome
- Medical subject headings
- Obesity, Morbid, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emblization of the gastro-epiploic arcadeProcedure or surgery
Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | Patients undergoing embolization of the gastro-epiploic arcade Receives: Procedure: Emblization of the gastro-epiploic arcade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 7 days post embolization
Number of participants with adverse events
Measured: 1 month post embolization
Number of participants with adverse events
Measured: 3 months post embolization
Number of participants with adverse events
Measured: 6 months post embolization
Number of participants with adverse events
Measured: 12 months post embolization
Secondary outcomes (6)
Change in weight
Weight loss expressed in percentage of total weight loss (%TWL)
Measured: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Change in abdominal circumference
Measurement of abdominal circumference in centimetres
Measured: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in thigh circumferences
Measurement of thigh circumferences in centimetres
Measured: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in Ghrelinemia
Measurement of serum ghrelin concentration
Measured: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in Quality of life
Quality of Life is scored using Moorehead-Ardelt II Quality of life questionnaire. The questionnaire involves 6 questions scored from -0,5 to +0,5. The mean of the 6 answers leads to a sum between -3 (very poor quality of life) to +3 (very good quality of life).
Measured: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Number of upper digestive endoscopies
Count of upper digestive endoscopies performed per patient during the study period
Measured: 12 months after bariatric embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start23 Mar 2020
- Primary completionApr 2024 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: Patients were selected but their very condition and the resulting comorbidities did not allow their inclusion. In addition, the health crisis prevented any bariatric operation of this complexity for an indefinite period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul POP, MD, PhD, Principal investigator, Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207424
- Sponsor's protocol ID
- 19-005
- Acronym
- Embargo
- Status last verified
- Mar 2022
- First submitted
- 16 Dec 2019
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogden CL, Carroll MD, Flegal KM. High body mass index for age among US children and adolescents, 2003-2006. JAMA. 2008 May 28;299(20):2401-5. doi: 10.1001/jama.299.20.2401.
PubMed 18505949Sturm R. Increases in morbid obesity in the USA: 2000-2005. Public Health. 2007 Jul;121(7):492-6. doi: 10.1016/j.puhe.2007.01.006. Epub 2007 Mar 30.
PubMed 17399752Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
PubMed 25105982Baptista V, Wassef W. Bariatric procedures: an update on techniques, outcomes and complications. Curr Opin Gastroenterol. 2013 Nov;29(6):684-93. doi: 10.1097/MOG.0b013e3283651af2.
PubMed 24100715Aina R, Oliva VL, Therasse E, Perreault P, Bui BT, Dufresne MP, Soulez G. Arterial embolotherapy for upper gastrointestinal hemorrhage: outcome assessment. J Vasc Interv Radiol. 2001 Feb;12(2):195-200. doi: 10.1016/s1051-0443(07)61825-9.
PubMed 11265883De Wispelaere JF, De Ronde T, Trigaux JP, de Canniere L, De Geeter T. Duodenal ulcer hemorrhage treated by embolization: results in 28 patients. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):6-11.
PubMed 12014319Defreyne L, Vanlangenhove P, De Vos M, Pattyn P, Van Maele G, Decruyenaere J, Troisi R, Kunnen M. Embolization as a first approach with endoscopically unmanageable acute nonvariceal gastrointestinal hemorrhage. Radiology. 2001 Mar;218(3):739-48. doi: 10.1148/radiology.218.3.r01mr05739.
PubMed 11230648Goldman ML, LAND WC, Bradley EL, Anderson RT. Transcatheter therapeutic embolization in the management of massive upper gastrointestinal bleeding. Radiology. 1976 Sep;120(3):513-21. doi: 10.1148/120.3.513.
PubMed 1085008Holme JB, Nielsen DT, Funch-Jensen P, Mortensen FV. Transcatheter arterial embolization in patients with bleeding duodenal ulcer: an alternative to surgery. Acta Radiol. 2006 Apr;47(3):244-7. doi: 10.1080/02841850600550690.
PubMed 16613304Lang EV, Picus D, Marx MV, Hicks ME. Massive arterial hemorrhage from the stomach and lower esophagus: impact of embolotherapy on survival. Radiology. 1990 Oct;177(1):249-52. doi: 10.1148/radiology.177.1.2399325.
PubMed 2399325Lieberman DA, Keller FS, Katon RM, Rosch J. Arterial embolization for massive upper gastrointestinal tract bleeding in poor surgical candidates. Gastroenterology. 1984 May;86(5 Pt 1):876-85.
PubMed 6608465Ljungdahl M, Eriksson LG, Nyman R, Gustavsson S. Arterial embolisation in management of massive bleeding from gastric and duodenal ulcers. Eur J Surg. 2002;168(7):384-90. doi: 10.1080/110241502320789050.
PubMed 12463427Miller M Jr, Smith TP. Angiographic diagnosis and endovascular management of nonvariceal gastrointestinal hemorrhage. Gastroenterol Clin North Am. 2005 Dec;34(4):735-52. doi: 10.1016/j.gtc.2005.09.001.
PubMed 16303580Morris DC, Nichols DM, Connell DG, Burhenne HJ. Embolization of the left gastric artery in the absence of angiographic extravasation. Cardiovasc Intervent Radiol. 1986;9(4):195-8. doi: 10.1007/BF02577940.
PubMed 3094950Ripoll C, Banares R, Beceiro I, Menchen P, Catalina MV, Echenagusia A, Turegano F. Comparison of transcatheter arterial embolization and surgery for treatment of bleeding peptic ulcer after endoscopic treatment failure. J Vasc Interv Radiol. 2004 May;15(5):447-50. doi: 10.1097/01.rvi.0000126813.89981.b6.
PubMed 15126653
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses
- ClinicalTrials.gov ID
- NCT04207424
- Acronym / sponsor ID
- Embargo / 19-005
- Conditions
- Morbid Obesity
- Keywords
- Bariatric embolization, Obesity, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients were selected but their very condition and the resulting comorbidities did not allow their inclusion. In addition, the health crisis prevented any bariatric operation of this complexity for an indefinite period.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 20 Dec 2019 (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 aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
Detailed description
Obesity is now an epidemic in the developed and developing world. Medical management is ineffective at population level. Metabolic surgery has been shown to be effective in achieving weight loss and controlling associated conditions. However, surgery is invasive and has associated complications. Furthermore, not every patient is interested in or eligible for surgery.
Bariatric gastric embolization recently emerged as a promising minimally invasive alternative to open bariatric surgery. Data from several initial pilot clinical trials suggests that gastric embolization is safe and can induce weight loss.
Previous studies have concentrated on left gastric artery embolization as the primary target vessel because it supplies the largest portion of the fundus. However, it may be desirable to target a different artery, specifically the left gastroepiploic which also supplies the fundus. The left gastric artery is spared in bariatric surgery because it supplies the residual pouch after the surgery. Embolization of the left gastric artery may result in worse healing in the event of follow-up surgery potentially excluding people should they subsequently want it or become eligible.
This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
The target population consists of adult, morbidly obese patients with contraindication for bariatric surgery. Patients included in the study will be followed up for 12 months post bariatric embolization. The primary end point is procedural safety, defined as number and severity of adverse events occurring during the study period. Secondary end points include weight loss, evolution of weight and thigh circumferences, evolution of serum ghrelin levels and evolution of quality of life indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Procedure: Emblization of the gastro-epiploic arcadePatients undergoing embolization of the gastro-epiploic arcade |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient aged ≥18 and ≤ 71 years old
- BMI ≥ 40 or BMI ≥ 35 in association with one of the following comorbidities: hypertension, type 2 diabetes, obstructive sleep apnea
- Relative contraindication to bariatric surgery
- Able to sign informed consent.
Key exclusion criteria (41 listed)
- General
- Impossible or unwilling to attend follow-up visits.
- Weight > 250kg (weight limit of angiography table)
- Confirmed allergy to intravenous contrast agents.
- Pregnancy, breast feeding or willingness to conceive during the following year
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 |
|---|---|---|
| Emblization of the gastro-epiploic arcadeEndovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles | Procedure or surgery | Embolization |
Primary outcome
Number of participants with adverse events
Time frame: 7 days post embolization
Number of participants with adverse events
Time frame: 1 month post embolization
Number of participants with adverse events
Time frame: 3 months post embolization
Number of participants with adverse events
Time frame: 6 months post embolization
Number of participants with adverse events
Time frame: 12 months post embolization
6 secondary outcomes
Change in weight
Time frame: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Change in abdominal circumference
Time frame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in thigh circumferences
Time frame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in Ghrelinemia
Time frame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in Quality of life
Time frame: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Number of upper digestive endoscopies
Time frame: 12 months after bariatric embolization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 18505949Ogden CL, Carroll MD, Flegal KM. High body mass index for age among US children and adolescents, 2003-2006. JAMA. 2008 May 28;299(20):2401-5. doi: 10.1001/jama.299.20.2401.
- Background: PubMed 17399752Sturm R. Increases in morbid obesity in the USA: 2000-2005. Public Health. 2007 Jul;121(7):492-6. doi: 10.1016/j.puhe.2007.01.006. Epub 2007 Mar 30.
- Background: PubMed 25105982Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
- Background: PubMed 24100715Baptista V, Wassef W. Bariatric procedures: an update on techniques, outcomes and complications. Curr Opin Gastroenterol. 2013 Nov;29(6):684-93. doi: 10.1097/MOG.0b013e3283651af2.
- Background: PubMed 11265883Aina R, Oliva VL, Therasse E, Perreault P, Bui BT, Dufresne MP, Soulez G. Arterial embolotherapy for upper gastrointestinal hemorrhage: outcome assessment. J Vasc Interv Radiol. 2001 Feb;12(2):195-200. doi: 10.1016/s1051-0443(07)61825-9.
- Background: PubMed 12014319De Wispelaere JF, De Ronde T, Trigaux JP, de Canniere L, De Geeter T. Duodenal ulcer hemorrhage treated by embolization: results in 28 patients. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):6-11.
- Background: PubMed 11230648Defreyne L, Vanlangenhove P, De Vos M, Pattyn P, Van Maele G, Decruyenaere J, Troisi R, Kunnen M. Embolization as a first approach with endoscopically unmanageable acute nonvariceal gastrointestinal hemorrhage. Radiology. 2001 Mar;218(3):739-48. doi: 10.1148/radiology.218.3.r01mr05739.
- Background: PubMed 1085008Goldman ML, LAND WC, Bradley EL, Anderson RT. Transcatheter therapeutic embolization in the management of massive upper gastrointestinal bleeding. Radiology. 1976 Sep;120(3):513-21. doi: 10.1148/120.3.513.
- Background: PubMed 16613304Holme JB, Nielsen DT, Funch-Jensen P, Mortensen FV. Transcatheter arterial embolization in patients with bleeding duodenal ulcer: an alternative to surgery. Acta Radiol. 2006 Apr;47(3):244-7. doi: 10.1080/02841850600550690.
- Background: PubMed 2399325Lang EV, Picus D, Marx MV, Hicks ME. Massive arterial hemorrhage from the stomach and lower esophagus: impact of embolotherapy on survival. Radiology. 1990 Oct;177(1):249-52. doi: 10.1148/radiology.177.1.2399325.
- Background: PubMed 6608465Lieberman DA, Keller FS, Katon RM, Rosch J. Arterial embolization for massive upper gastrointestinal tract bleeding in poor surgical candidates. Gastroenterology. 1984 May;86(5 Pt 1):876-85.
- Background: PubMed 12463427Ljungdahl M, Eriksson LG, Nyman R, Gustavsson S. Arterial embolisation in management of massive bleeding from gastric and duodenal ulcers. Eur J Surg. 2002;168(7):384-90. doi: 10.1080/110241502320789050.
- Centers for Disease Control and Prevention. Adult obesity facts.Link 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. This study is not recruiting at the moment.
Raoul POP, MD, PhD principal investigator
Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg
Questions about this trial
What is this clinical trial studying?
A study testing Emblization of the gastro-epiploic arcade in people with Morbid Obesity, run by IHU Strasbourg.
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 4 inclusion and 41 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: withdrawn, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 7 days post embolization). The study lists 5 primary outcomes in all. 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 NCT04207424, which also lists 24 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 17 Apr 2026.