Bariatric Embolization of Arteries for the Treatment of Obesity

Study Overview
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Brief Summary
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The purpose of this study is evaluate the safety and effectiveness of bariatric embolization as a minimally-invasive image-guided procedure for morbid obesity. In this procedure, specific blood vessels to the stomach are blocked in order to suppress some of the body's signals for feeling hungry, leading to weight loss. Morbid obesity is currently treated with diet and exercise, medications, and surgery. This study is designed to help treat obesity using a minimally invasive, non-surgical, angiographic (through the blood vessel) approach. This procedure is similar to a common procedure used to treat bleeding within the stomach. This version of the procedure has been named bariatric embolization. Although there are over 40 hormones that limit food intake, there is only one hormone, ghrelin that has been shown to stimulate (prompt) food intake. In obese patients, eating fails to suppress ghrelin levels, which is believed to prevent feeling full after a meal and to lead to overeating. Due to the strong hunger craving effects of ghrelin, this hormone has been a target for the treatment of obesity and weight loss. More recently, ghrelin has been shown to have a significant role in the long-term effect of weight loss in bariatric (obesity) surgery where ghrelin levels are shown to be much lower when compared to untreated patients. Recent data collected in animals in has shown that blocking blood vessels to a particular portion of the stomach (bariatric embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and decrease short-term weight gain. In a study of 5 people, there was a decrease in ghrelin levels and weight loss in the first month after the procedure, but there is no information about the effects of the procedure over longer periods of time. The investigator hopes to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.

Official Title
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Bariatric Embolization of Arteries for the Treatment of Obesity

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Artificial Embolization Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing, able and mentally competent to provide written informed consent. Body mass index (BMI) between 40-60. Residence within 25 miles of the enrolling institution Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography. Suitable for protocol therapy as determined by the interventional radiology Investigator. Adequate hematological, hepatic and renal function as follows: Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L International Normalized Ratio (INR) <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated Glomerular Filtration Rate (GFR) > 60ml/min.1.73m2 Aged 18 years or older. Exclusion Criteria: Prior history of gastric pancreatic, hepatic, and/or splenic surgery Prior radiation to the upper abdomen Prior embolization to the stomach, spleen or liver Portal venous hypertension Prior or current history of peptic ulcer disease Hiatal Hernia Significant risk factors for peptic ulcer disease including daily NSAID use and smoking. Active H. Pylori infection Weight greater than 400 pound Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease. Complicated arterial anatomic variants including left gastric artery arising from the aorta, and/or hepatic arterial supply via a replaced or accessory left hepatic artery arising from the left gastric artery. Pregnancy Preexisting chronic abdominal pain Positive stool occult study Abnormal Endoscopy Abnormal Nuclear Gastric Motility examination American Society of Anaesthesiologists (ASA) Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects. History of Inflammatory Bowel Disease Autoimmune disease Cirrhosis Known history of allergy to iodinated contrast media

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/Bariatric Embolization<br> | Device: Artificial Embolization Device<br>* Embosphere Microspheres<br>* Other names: Regulation Numbers: 21 CFR 882.5950;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Change | This will be assessed by Percentage of excess weight loss (EWL). Percentage of excess weight loss is calculated by measuring the participants excess weight at baseline and then calculating the percentage of excess weight that was lost 12 months after surgery (for example if a participant has 100 pounds of excess weight prior to surgery and loses 30 pounds, their excess weight loss would be 30%). | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Morbid Obesity, Bariatric Surgery, Embolization, Minimally Invasive, Weight Loss