Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% 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 subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2.
详细描述
LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a BMI ≥ 30 kg/m2 and < 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and < 40 kg/m2 without severe comorbid 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
- •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 Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation
时间窗: One year
The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.
次要结局
- Percent Weight Loss(Baseline through 12 months)
- Change in Comorbid Conditions Related to Obesity(12 months)
- Change in Quality of Life(12 months)