NCT00999661已完成不适用
A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients
Ethicon Endo-Surgery0 个研究点目标入组 231 人开始时间: 2009年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 主要终点
- Percent Excess Weight Change From Baseline to 24 Months
研究概览
简要总结
The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received an implant with the Realize Band-C according to the following indications for use:
- •Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions.
- •Male and female adult patients (adult is defined as 18 years of age or older)
- •Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.
- •Able to comprehend, follow, and give signed informed consent.
排除标准
- •Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
- •Severe cardiopulmonary disease or other serious organic disease;
- •Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
- •Portal hypertension;
- •Anomalies of the gastrointestinal tract such as atresia or stenosis;
- •Cirrhosis of the liver;
- •Chronic pancreatitis;
- •Localized or systemic infection;
- •On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;
- •Unable or unwilling to comply with dietary restrictions required by this procedure;
- •Known allergy to materials contained in the gastric band or its Injection Port;
- •Women who are pregnant;
- •Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.
结局指标
主要结局
Percent Excess Weight Change From Baseline to 24 Months
时间窗: Baseline to 24 months
Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
次要结局
- % Excess Weight Change From Baseline to 12 Months(Baseline to 12 months)
- Change in Body Mass Index From Baseline to 24 Months(Baseline to 24 months)
研究者
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