Bariatric Embolization of Arteries for the Treatment of Obesity
关键词
抽象
日期
最后验证: | 10/31/2018 |
首次提交: | 06/10/2014 |
提交的预估入学人数: | 06/12/2014 |
首次发布: | 06/16/2014 |
上次提交的更新: | 10/31/2018 |
最近更新发布: | 11/04/2018 |
首次提交结果的日期: | 09/23/2018 |
首次提交质量检查结果的日期: | 10/31/2018 |
首次发布结果的日期: | 11/04/2018 |
实际学习开始日期: | 05/31/2014 |
预计主要完成日期: | 11/30/2017 |
预计完成日期: | 02/28/2018 |
状况或疾病
干预/治疗
Device: Intervention/Bariatric Embolization
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Intervention/Bariatric Embolization | Device: Intervention/Bariatric Embolization Embosphere Microspheres |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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 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 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. 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. 19. History of Inflammatory Bowel Disease 20. Autoimmune disease 21. Cirrhosis 22. Known history of allergy to iodinated contrast media |
结果
主要结果指标
1. Percent Weight Change [12 Months]
其他成果措施
1. Blood Pressure [12 Months]
2. Lipid Panel [12 Months]
3. Ghrelin Levels [12 Months]
4. Serum Obesity Hormone(Leptin) [12 Months]
5. Eating and Hunger/Satiety Assessments [12 Months]
6. Quality of Life Parameters Survey [12 Months]
7. Food Intake [12 Months]
8. Results From Endoscopy [12 Months]
9. Gastric Motility/Emptying [12 Months]