Effectiveness Gastric Balloon in Obese Adolescents
Not Applicable
Not yet recruiting
- Conditions
- Obesity, Morbid
- Interventions
- Device: gastric balloon
- Registration Number
- NCT04209842
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
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).
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gastric ballon placement gastric balloon will receive gastric balloon placed via endoscopy
- Primary Outcome Measures
Name Time Method change from baseline weight 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lucille Packard Children's Hospital
🇺🇸Palo Alto, California, United States