Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.
研究概览
简要总结
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
详细描述
The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 14 and 17 at the time of enrollment
- •Have a BMI ≥ 40 kg/m2 (with or without obesity-related co-morbid conditions) or BMI ≥ 35 kg/m2 with one or more severe co-morbid conditions
- •Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs
排除标准
- •Family or subject history of congenital or acquired anomalies of the gastrointestinal tract
- •Severe cardiopulmonary or other serious or uncontrolled organic disease
- •Severe coagulopathy; hepatic insufficiency or cirrhosis
- •History of bariatric, gastric, or esophageal surgery
- •History of intestinal obstruction or adhesive peritonitis
- •History of esophageal dysmotility disorders
- •Type I diabetes
结局指标
主要结局
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.
时间窗: 1 year
Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years.
次要结局
- Change in Subjects' Comorbid Conditions(Baseline to 5 Years)
- Change in Quality of Life Using the Beck Depression Inventory II (BDI)(Baseline to 5 Years)
- Subject Percent Excess BMI Loss(Baseline to 5 Years)
- Subject Excess Weight Loss Throughout the Study(Baseline to 5 Years)
- Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire(Baseline to 5 Years)