Bariatric Embolization of Arteries for the Treatment of Obesity
This trial is active, not recruiting.
|Treatment||artificial embolization device|
|Sponsor||Johns Hopkins University|
|Collaborator||Icahn School of Medicine at Mount Sinai|
|Start date||June 2014|
|End date||September 2016|
|Trial size||20 participants|
|Trial identifier||NCT02165124, NA_00093563|
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.
We hope to learn if bariatric embolization results in safe and effective weight loss in people who are morbidly obese.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 12 Months
Number of Patients with Adverse Events
time frame: 30 Days
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: 1. Willing, able and mentally competent to provide written informed consent. 2. Body mass index (BMI) between 40-60. 3. Residence within 25 miles of the enrolling institution 4. 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. 5. Suitable for protocol therapy as determined by the interventional radiology Investigator. 6. Adequate hematological, hepatic and renal function as follows: Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2 7. Aged 18 years or older. Exclusion Criteria: 1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery 2. Prior radiation to the upper abdomen 3. Prior embolization to the stomach, spleen or liver 4. Portal venous hypertension 5. Prior or current history of peptic ulcer disease 6. Hiatal Hernia 7. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking. 8. Active H. Pylori infection 9. Weight greater than 400 pound 10. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute 11. Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease. 12. 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. 13. Pregnancy 14. Preexisting chronic abdominal pain 15. Positive stool occult study 16. Abnormal Endoscopy 17. Abnormal Nuclear Gastric Motility examination 18. 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. 19. History of Inflammatory Bowel Disease 20. Autoimmune disease 21. Cirrhosis 22. Known history of allergy to iodinated contrast media
|Official title||Bariatric Embolization of Arteries for the Treatment of Obesity|
|Principal investigator||Clifford R Weiss, M.D.|
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