NCT04209842尚未招募不适用
Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- change from baseline weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
结局指标
主要结局
change from baseline weight
时间窗: 6 months
次要结局
未报告次要终点
研究者
Roberto Gugig
professor of pediatrics
Stanford University
研究点 (2)
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