NCT00960843已完成不适用
A Randomized, Controlled, 6-month Study to Compare the Effects of Volume- and Pressure-guided Adjustments on Weight Loss and Satiety in Patients Implanted With the Swedish Adjustable Gastric Band
Ethicon Endo-Surgery3 个研究点 分布在 2 个国家目标入组 51 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Percent Excess Weight Change at Day 180
研究概览
简要总结
The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Able to comprehend, follow and give informed consent.
- •Be at least 18 years of age at time of trial enrollment.
- •Had a pre-implantation BMI between 35 and 55 kg/m
- •Have received a SAGB VC implant 1) 30-60 days (and not undergone first band adjustment yet)prior to the date of enrollment.
- •Willingness to be randomized to intraband-based or conventional adjustments
- •Willingness to consent to monthly visits and possible measurements of intraband pressure (requiring access to the injection port).
- •Willingness to undergo up to 7 band adjustments within the 6-month period of the study.
- •Able to sit approximately at a 90 degree-angle, from the floor, for IBP measurements.
- •Willingness to return to office visits around the same time of the first in-study adjustment (plus or minus 2 hours)
- •Willingness to consent to a limited UGI series if the investigator suspects the presence of a band-related complication or if the intraband pressure recordings deviate from expected.
- •Willingness to refrain from taking medications or supplements indicated for or known to induce weight loss.
排除标准
- •Females currently known to be pregnant.
- •Ongoing or unresolved band perforation or band leakage.
- •Ongoing (unresolved) slippage, erosion, or pouch dilation.
- •Documented esophageal dysmotility/dyskinesia.
- •Ongoing (unresolved) port obstruction or tube kinking.
- •Current injection port infection.
- •History of band revision or replacement.
- •Previously documented or ongoing esophageal dilatation.
- •Any condition that, in the opinion of the Investigator, may jeopardize the subject's well-being or the soundness of this study.
- •Current use of medications or supplements indicated for or known to induce weight loss at any point during the study.
结局指标
主要结局
Percent Excess Weight Change at Day 180
时间窗: Screening to Day 180
Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.
次要结局
- Mean Static Intraband Pressure at Day 180(Day 180)
- Rate of Weight Loss kg/wk at Day 180(Screening to Day 180)
研究者
研究点 (3)
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