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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.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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;