Status:
COMPLETED
Pilot Study to Evaluate A Novel Gastric Space Occupying Device
Lead Sponsor:
Obalon Therapeutics, Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
- Have gastroparesis;
- Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
- Currently using pharmaceutical agents for weight loss;
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01444274
Start Date
July 1 2011
End Date
September 1 2011
Last Update
March 15 2019
Active Locations (1)
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1
Obesity Control Center
Tijuana, Estado de Baja California, Mexico, 22320