A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Percentage of Excess Weight Loss (EWL)
研究概览
简要总结
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
详细描述
STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.
STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).
DESIGN:Prospective, open-label, and single center
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
- •Be at least 14 and less than 18 years of age at the time of enrollment into the study.
- •Have a BMI of at least 40
- •Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity.
- •Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol.
- •Express willingness to follow protocol requirements.
- •Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.
排除标准
- •Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement.
- •History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis.
- •Presence of dysphagia or documented esophageal dysmotility.
- •Patients with autoimmune connective tissue disorders
- •Patients with acute abdominal infections
- •Pregnancy or intention of becoming pregnant in the next 12 months.
- •Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol.
- •History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis.
- •Presence of localized or systemic infection at the time of surgery.
- •Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications.
- •History of gastric or esophageal surgery.
- •Use of weigh loss medications simultaneously
研究组 & 干预措施
Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
干预措施: Lap-Band (Device)
结局指标
主要结局
Percentage of Excess Weight Loss (EWL)
时间窗: Year 5
Percentage of Excess Weight Loss (EWL)
时间窗: Year 1
Percentage of Excess Weight Loss (EWL)
时间窗: Year 2
Percentage of Excess Weight Loss (EWL)
时间窗: Year 3
Percentage of Excess Weight Loss (EWL)
时间窗: Year 4
次要结局
- Body Mass Index (BMI)(Year 5)
- Body Mass Index (BMI)(Year 3)
- Body Mass Index (BMI)(Year 4)
- Body Mass Index (BMI)(Year 1)
- Body Mass Index (BMI)(Year 2)