Overweight, obese Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
This will be an observational study where patients will serve as their own contol. No independent control group will be evaluated. Baseline weight, body mass index (BMI) and waist circumference will b
Sponsors
Obalon Therapeutics, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 21 - 64 years, either sex 2. Body mass index (BMI) 27 - 40 kg/m2 3. No history of weight reduction of more than 5% of total body weight in the past 6 months 4. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography, as well as clinical lab testing. 5. Must be able to understand and be willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Have unstable angina, myocardial infarction within the past year or heart disease classified within the New York Heart Association (NYHA) Class III or IV functional capacity 2. 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 3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months 4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin 5. History or symptoms of thyroid disease which is not controlled by medication 6. Have severe renal, hepatic, pulmonary disease or cancer 7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy) 8. Have a history of adhesive peritonitis 9. History or symptoms of esophageal and/or gastric varices 10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and/or diverticula) 11. History or symptoms of inflammatory bowel disease, such as Crohn's disease 12. History of/signs and/or symptoms of duodenal or gastric ulcer 13. Have gastroporesis 14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential) 15. Currently using pharmaceutical agents for weight loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, characterised by the incidence of all adverse device effects (ADEs), possibly related to or related to the procedure and/or device, experienced by study participants. Adverse device effects are collected at a minimum weekly (day 7, 14, 21, and 28 +/- 2 days); however, they are documented at any time the patient notifies the study staff of a concern. There is no formal endpoint and the sample size does not support a formal endpoint to be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Information on preliminary efficacy, obtained by measurements of total weight loss and excess weight loss during the 30 days of device use as compared to baseline | — |
Countries
Mexico
Outcome results
None listed