Use of the REALIZE™ Adjustable Gastric Band (Model 2200-X) in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.
详细描述
Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to help the participant loose weight along with healthy eating, diet and exercise. This study involves minimally invasive laparoscopic surgery to place the adjustable band around the upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball. One end of the band ends with a flat balloon that goes around the upper part of the stomach. The opening from this small stomach can be changed to allow more or less food into the intestine depending on the amount eaten and the amount of weight lost.
The other end of the of the band ends in a filling port through which saline solution is pumped with a needle through an attached tube to inflate or deflate the balloon. The filling port is attached to the wall of the abdomen under the skin. Because the flow of food is regulated by the band, most people feel full faster. This is how the appetite for food is controlled and the why the person is likely to eat less with the band in place.
Food is digested through the normal digestive process.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5
排除标准
- ••Hypertension: Systolic blood pressure (SBP) of 140 mm Hg
- •Hyperlipidemia: hyperlipidemia depends on
- •Obstructive Sleep Apnea:
- •Metabolic Syndrom: The presence of any three of the following: abdominal obesity - dimensons for children? triglycerides -cholesterol -
- •fasting glucose
- •blood pressure
- •overweight
- •Non-surgical means of weight reduction failure of
- •Significant psychopathology (absence of ) that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment;
- •Agrees to refrain from any type of reconstructive surgery that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for three years following SAGB placement; and
- •Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery.
结局指标
主要结局
Weight loss
时间窗: Monthly up to one year
Reduction in percent of excess weight loss (%EWL).
次要结局
未报告次要终点