ObesityNCT02933554
Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis
A study testing Embospheres Microspheres in people with Obesity and Weight Loss, run by Keith Pereira, MD: at 1 site in United States.
Trial summary
Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Body Weight
- What is being tested?
- Embospheres Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Jun 2027
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female, aged 22 years or older.
- Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study
- BMI >35 kg/m2
- Adequate hematological, hepatic and renal function as follows:
- Hematological: Hematological: If the bariatric embolization procedure is being performed by femoral access: platelets > 50 x 109/L, INR <1.5. If the bariatric embolization procedure is being performed by radial access: platelets >35 x 109/L and INR <1.5 OR platelets >50 x 109/L and INR between 1.5 and 2."
- Hepatic : Total bilirubin <3 mg/dL
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- Renal: Estimated GFR > 60ml/min.1.73m2
- If Center for Epidemiological Studies Depression (CESD) score > or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.
- Elevated alanine or aspartate aminotransferase values (ALT >41 or AST>34 U/L).
- Liver biopsy showing evidence of NASH in the past 12 months.
- No evidence of another form of liver disease.
- Patients diagnosed with NASH and have evidence of failing other methods of weight loss through diet, exercise and behavior modification.
Who cannot join
- Pregnancy
- Active substance abuse
- Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score > or = 16 without psychiatric evaluation. [If Center for Epidemiological Studies Depression (CESD) score > or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.]
- Significant alcohol consumption ( >20 g/day in women, >30 g/day in men)
- Weight > 400 lbs, BMI > 50 kg/m2.
- Contraindications to obtaining a liver biopsy
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- Subjects with pre-existing abdominal pain will be excluded (because of the potential confusion with pain related to the procedure).
- Subjects who are intolerant to PPIs
- Subjects requiring any anticoagulant medications should be excluded if radial access cannot be obtained.
- Subjects with platelets <35 x 109/L and INR > 2.0
- Subjects who are taking aspirin/ NSAIDs and in whom these medications are unable to be withdrawn from aspirin and NSAIDs for at least 3 days prior to the LGAE procedure and for 30 days following the LGAE procedure (because of the potential risks of gastric bleeding following the procedure).
- Presence of systemic illness or other medical conditions relevant to survival .(Note that in the HCC pre liver transplant cohort, the presence of HCC will not be considered an exclusion criteria)
- Metastatic cancer
- Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)
- prior surgical weight loss procedures including gastroplasty, jejunoileal, or jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history of gastric pancreatic, hepatic, and/or splenic surgery
- Prior embolization to the stomach, spleen or liver, unless the prior embolization was a transarterial chemoembolization (TACE) to the liver for HCC.
- If review of available prior imaging studies (i.e CT, MRI, or US)shows potential anatomical variations, presence of severe atheromatous disease, large arteriovenous shunting of blood.
- Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active peptic ulcer disease, active H. pylori infection
- History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying of gastric contents > 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively.
- ASA Class 4 or 5
- Child Pugh classification C
- Known aortic disease, such as dissection or aneurysm; peripheral arterial disease or other cardiovascular disease.
- Type 2 diabetes on anti-diabetic medications that are known to cause hypoglycemia. e.g. sulphonylureas, meglitinides
- Patients with a known other cause for their increased liver enzyme levels such as viral hepatitis (B or C), autoimmune/chronic immune hepatitis, primary biliary cholangitis, metabolic and genetic hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency
- Patient taking hepatotoxic drugs. List of drugs causing steatohepatitis include but are not limited to: amiodarone, chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase), glucocorticoids, methotrexate, sulfonamides, antithyroid drugs, phenytoin, tetracyclines, isoniazid, salicylates, and valproic acid.
- Contraindications to obtaining a liver biopsy (NASH cohort)
- Patients taking other trial medications for NASH.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization, to Promote Short-term Weight Loss in Obese Patients With Nonalcoholic Steatohepatitis (NASH) and Thereby Improve NASH
Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.
Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.
Read the detailed description
Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated that, by the year 2030, 38% of the world's adult population will be overweight and another 20% obese.An expert panel convened by the NIH stated that for the first time in history, the steadily improving worldwide life expectancy could level off or even decline, as the result of increasing obesity.
NAFLD and NASH:
The Problem: Obesity is a chronic disease that is strongly associated with a number of diseases with an increase in mortality and morbidity. Metabolic syndrome (obesity, diabetes mellitus, hyperlipidemia) has been established as risk factor for primary nonalcoholic fatty liver disease (NAFLD) .In the US, recent estimates suggest that NAFLD affects 30% of the general population, 90% of the morbidly obese . NAFLD can progress to nonalcoholic steatohepatitis (NASH) in up to 25% . Of patients with NASH progression of fibrosis is seen in 26-37% and progressing to cirrhosis in 9-25 % . NASH cirrhosis can result in liver failure, portal hypertension, and hepatocellular carcinoma(HCC) .
Current options in management of NASH: The goal of managing NASH is to eliminate risk factors and preventing fibrosis by treating metabolic syndrome, primarily obesity [10]. Although dietary modification and exercise can achieve weight loss, this is difficult to sustain . Very few effective medical therapies are available, and are associated with adverse effects. Although weight loss after bariatric surgery has demonstrated histological improvement in NASH, a recent Cochrane review concluded that there is insufficient data to determine if bariatric surgery is an effective treatment. Also high mortality rates are seen post-bariatric surgery.
Thus a safe and effective minimally invasive option is needed. Based on currently available data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of about 10.5% in 3-6 months, with a high safety profile. In patients with NAFLD, a 3-5% weight loss is thought to improve steatosis, 7- 10% may be needed to improve necroinflammation. Thus, LGAE has the potential to reverse the histology of NASH to prevent progression to cirrhosis, HCC and its sequale.
- Conditions
- Obesity, Weight Loss, Body Weight, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease, NAFLD
- Being tested
- Embospheres Microspheres
- Keywords
- bariatric surgery, minimally invasive, Embolization, NASH, ghrelin, gastric artery embolization
- Medical subject headings
- Obesity, Weight Loss, Body Weight, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embospheres MicrospheresDevice
Also called Bariatric embolization
Via a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.
| Study group | Role | What they receive |
|---|---|---|
| NASH- Left gastric artery embolization | Experimental | Embospheres Microspheres as artificial embolic agent for left gastric artery embolization Receives: Device: Embospheres Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Total body Weight loss > 10 % in 12 months
Measured: 12 months
Secondary outcomes (10)
Clinical parameter- Abdominal circumference
Improvement in abdominal circumference measured in centimeters (cm)
Measured: 12 months
Clinical parameter-Blood pressure
Improvement in blood pressure measured in mmHg
Measured: 12 months
Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)
Reduction in serum Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY) measured in pg/mL
Measured: 12 months
Laboratory parameter-serum glucose
Reduction in serum glucose levels measured as mg/dL
Measured: 12 months
Laboratory parameters- HbA1c
Reduction in HbA1c measures as percentage(%)
Measured: 12 months
Laboratory parameters-Lipid profile
Improvement in lipid profile measured as mg/dL
Measured: 12 months
Number of patients with clinical adverse events
Adverse events like pain, ischemia
Measured: 12 months
Results from endoscopy
Photos and clinical reports analyzed
Measured: 12 months
Change in inflammation, fibrosis, steatosis in liver histology
Change in liver histology between baseline and 12 months in liver histology
Measured: 12 months
NAFLD activity score
Change in NAFLD Activity score (Kleiner) between baseline and 12 months in liver histology
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keith Pereira, MD:
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Keith Pereira, MD:, St. Louis University
- Investigators
- Keith Pereira, MD, Principal investigator, Assistant professor of radiology-Interventional radiologyBrent Neuschwander-Tetri, MD, Principal investigator, Professor of medicine- gastroenterologyKirubahara Vaheesan, MD, Principal investigator, Assistant professor of radiology- Interventional radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933554
- Sponsor's protocol ID
- 27420-NASH
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2016
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.
PubMed 22488764Caldwell S, Argo C. The natural history of non-alcoholic fatty liver disease. Dig Dis. 2010;28(1):162-8. doi: 10.1159/000282081. Epub 2010 May 7.
PubMed 20460906Dyson JK, Anstee QM, McPherson S. Non-alcoholic fatty liver disease: a practical approach to treatment. Frontline Gastroenterol. 2014 Oct;5(4):277-286. doi: 10.1136/flgastro-2013-100404. Epub 2014 Jan 22.
PubMed 25285192Arepally A, Barnett BP, Montgomery E, Patel TH. Catheter-directed gastric artery chemical embolization for modulation of systemic ghrelin levels in a porcine model: initial experience. Radiology. 2007 Jul;244(1):138-43. doi: 10.1148/radiol.2441060790.
PubMed 17581899Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232.
PubMed 18796671Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.
PubMed 22367009Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.
PubMed 24462005Kipshidze N, Archvadze A, Bertog S, Leon MB, Sievert H. Endovascular Bariatrics: First in Humans Study of Gastric Artery Embolization for Weight Loss. JACC Cardiovasc Interv. 2015 Oct;8(12):1641-4. doi: 10.1016/j.jcin.2015.07.016. No abstract available.
PubMed 26493259Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.
PubMed 27567998Gunn AJ, Oklu R. A preliminary observation of weight loss following left gastric artery embolization in humans. J Obes. 2014;2014:185349. doi: 10.1155/2014/185349. Epub 2014 Sep 30.
PubMed 25349724Salsamendi J, Pereira K, Kang K, Fan J. Minimally invasive percutaneous endovascular therapies in the management of complications of non-alcoholic fatty liver disease (NAFLD): A case report. J Radiol Case Rep. 2015 Sep 30;9(9):36-43. doi: 10.3941/jrcr.v9i9.2557. eCollection 2015 Sep.
PubMed 26629307
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization, to Promote Short-term Weight Loss in Obese Patients With Nonalcoholic Steatohepatitis (NASH) and Thereby Improve NASH
- ClinicalTrials.gov ID
- NCT02933554
- Acronym / sponsor ID
- 27420-NASH
- Conditions
- Obesity, Weight Loss, Body Weight, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease, NAFLD
- Keywords
- bariatric surgery, minimally invasive, Embolization, NASH, ghrelin, gastric artery embolization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Keith Pereira, MD:University, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.
Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.
Detailed description
Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated that, by the year 2030, 38% of the world's adult population will be overweight and another 20% obese.An expert panel convened by the NIH stated that for the first time in history, the steadily improving worldwide life expectancy could level off or even decline, as the result of increasing obesity.
NAFLD and NASH:
The Problem: Obesity is a chronic disease that is strongly associated with a number of diseases with an increase in mortality and morbidity. Metabolic syndrome (obesity, diabetes mellitus, hyperlipidemia) has been established as risk factor for primary nonalcoholic fatty liver disease (NAFLD) .In the US, recent estimates suggest that NAFLD affects 30% of the general population, 90% of the morbidly obese . NAFLD can progress to nonalcoholic steatohepatitis (NASH) in up to 25% . Of patients with NASH progression of fibrosis is seen in 26-37% and progressing to cirrhosis in 9-25 % . NASH cirrhosis can result in liver failure, portal hypertension, and hepatocellular carcinoma(HCC) .
Current options in management of NASH: The goal of managing NASH is to eliminate risk factors and preventing fibrosis by treating metabolic syndrome, primarily obesity [10]. Although dietary modification and exercise can achieve weight loss, this is difficult to sustain . Very few effective medical therapies are available, and are associated with adverse effects. Although weight loss after bariatric surgery has demonstrated histological improvement in NASH, a recent Cochrane review concluded that there is insufficient data to determine if bariatric surgery is an effective treatment. Also high mortality rates are seen post-bariatric surgery.
Thus a safe and effective minimally invasive option is needed. Based on currently available data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of about 10.5% in 3-6 months, with a high safety profile. In patients with NAFLD, a 3-5% weight loss is thought to improve steatosis, 7- 10% may be needed to improve necroinflammation. Thus, LGAE has the potential to reverse the histology of NASH to prevent progression to cirrhosis, HCC and its sequale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NASH- Left gastric artery embolization | Experimental | Device: Embospheres MicrospheresEmbospheres Microspheres as artificial embolic agent for left gastric artery embolization |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or Female, aged 22 years or older.
- Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study
- BMI >35 kg/m2
- Adequate hematological, hepatic and renal function as follows:
- If Center for Epidemiological Studies Depression (CESD) score > or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.
Key exclusion criteria (27 listed)
- Pregnancy
- Active substance abuse
- Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score > or = 16 without psychiatric evaluation. [If Center for Epidemiological Studies Depression (CESD) score > or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.]
- Significant alcohol consumption ( >20 g/day in women, >30 g/day in men)
- Weight > 400 lbs, BMI > 50 kg/m2.
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 |
|---|---|---|
| Embospheres MicrospheresAlso: Bariatric embolizationVia a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry. | Device | NASH- Left gastric artery embolization |
Primary outcome
Weight
Time frame: 12 months
Total body Weight loss > 10 % in 12 months
10 secondary outcomes
Clinical parameter- Abdominal circumference
Time frame: 12 months
Clinical parameter-Blood pressure
Time frame: 12 months
Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)
Time frame: 12 months
Laboratory parameter-serum glucose
Time frame: 12 months
Laboratory parameters- HbA1c
Time frame: 12 months
Laboratory parameters-Lipid profile
Time frame: 12 months
Number of patients with clinical adverse events
Time frame: 12 months
Results from endoscopy
Time frame: 12 months
Change in inflammation, fibrosis, steatosis in liver histology
Time frame: 12 months
NAFLD activity score
Time frame: 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 28 Jul 2025.
- Results publication: PubMed 22488764Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.
- Results publication: PubMed 20460906Caldwell S, Argo C. The natural history of non-alcoholic fatty liver disease. Dig Dis. 2010;28(1):162-8. doi: 10.1159/000282081. Epub 2010 May 7.
- Results publication: PubMed 25285192Dyson JK, Anstee QM, McPherson S. Non-alcoholic fatty liver disease: a practical approach to treatment. Frontline Gastroenterol. 2014 Oct;5(4):277-286. doi: 10.1136/flgastro-2013-100404. Epub 2014 Jan 22.
- Results publication: PubMed 17581899Arepally A, Barnett BP, Montgomery E, Patel TH. Catheter-directed gastric artery chemical embolization for modulation of systemic ghrelin levels in a porcine model: initial experience. Radiology. 2007 Jul;244(1):138-43. doi: 10.1148/radiol.2441060790.
- Results publication: PubMed 18796671Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232.
- Results publication: PubMed 22367009Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.
- Results publication: PubMed 24462005Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.
- Results publication: PubMed 26493259Kipshidze N, Archvadze A, Bertog S, Leon MB, Sievert H. Endovascular Bariatrics: First in Humans Study of Gastric Artery Embolization for Weight Loss. JACC Cardiovasc Interv. 2015 Oct;8(12):1641-4. doi: 10.1016/j.jcin.2015.07.016. No abstract available.
- Results publication: PubMed 27567998Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.
- Results publication: PubMed 25349724Gunn AJ, Oklu R. A preliminary observation of weight loss following left gastric artery embolization in humans. J Obes. 2014;2014:185349. doi: 10.1155/2014/185349. Epub 2014 Sep 30.
- Results publication: PubMed 26629307Salsamendi J, Pereira K, Kang K, Fan J. Minimally invasive percutaneous endovascular therapies in the management of complications of non-alcoholic fatty liver disease (NAFLD): A case report. J Radiol Case Rep. 2015 Sep 30;9(9):36-43. doi: 10.3941/jrcr.v9i9.2557. eCollection 2015 Sep.
- 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.
Keith Pereira, MD principal investigator
Assistant professor of radiology-Interventional radiology
Brent Neuschwander-Tetri, MD principal investigator
Professor of medicine- gastroenterology
Kirubahara Vaheesan, MD principal investigator
Assistant professor of radiology- Interventional radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embospheres Microspheres in people with Obesity and Weight Loss, run by Keith Pereira, 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 12 inclusion and 27 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 Jul 2025. 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 Keith Pereira, MD (314-268-5558, keith.pereira@health.slu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 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 NCT02933554, which also lists 11 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 28 Jul 2025.