Study to Evaluate Novel Gastric Space Occupying Device
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.
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Ages Eligible for Study:
21 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients will be selected from a community sample that satisfy the inclusion/exclusion criteria.
Age between 21-64 years
BMI 27-40 Kg/m2
No history of weight reduction of more than 5% of total body weight in the past 6 months
Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
History or symptoms of thyroid disease which is not controlled by medication;
Have severe renal, hepatic, pulmonary disease or cancer;
Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
Have a history of adhesive peritonitis;
History or symptoms of esophageal and/or gastric varices;
Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
History or symptoms of inflammatory bowel disease, such as Chron's disease;
History of/ signs and /or symptoms of duodenal or gastric ulcer;
Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
Currently using pharmaceutical agents for weight loss;