Obesity, Morbid
Conditions
Brief summary
Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.
Interventions
DEVICEgastric balloon
non surgical weight loss via placement of gastric balloon
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI \> 3.5 SD) * Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised
Exclusion criteria
* Previous esophageal or gastric surgery or history of intestinal obstruction; * History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis * Hiatus hernia \>5 cm or \<5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion); * History of significant psychological disorder (permission sought from lead care giver).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline weight | 6 months |
Countries
United States
Outcome results
None listed