Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johns Hopkins University
With
Icahn School of Medicine at Mount Sinai
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Clareo Health | Bariatric Embolization of Arteries for the Treatment of Obesity
