LAP-BAND AP Early Experience Trial (APEX)
2015年1月15日 更新者：Apollo Endosurgery, Inc.
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
研究概览
详细说明
The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting.
Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements.
Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.
研究类型
观察性的
注册 (实际的)
521
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Austin、Texas、美国、78746
- Apollo Endosurgery
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Community sample
描述
Inclusion Criteria:
- Patient is scheduled to receive the LAP-BAND AP System
- Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.
Exclusion Criteria:
- Per the LAP-BAND AP System Directions For Use (DFU)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
LAP-BAND
Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.
|
Reduction of food intake due to creation of smaller stomach pouch.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Percent Excess Weight
大体时间：Baseline to 5 Years
|
Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured.
Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.
|
Baseline to 5 Years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
大体时间：Baseline to 5 years
|
Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
|
Baseline to 5 years
|
|
Subject Reported Satiety
大体时间：Baseline to 5 Years
|
Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits.
Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt.
Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt.
Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.
|
Baseline to 5 Years
|
|
Subject Reported Quality of Life
大体时间：Baseline to 5 Years
|
Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17).
The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).
|
Baseline to 5 Years
|
|
Subject Reported Sleepiness (Epworth Sleepiness Scale)
大体时间：Baseline to 5 years
|
The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness.
Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).
|
Baseline to 5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Apollo Endosurgery、Apollo Endosurgery, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ponce J, Taheri S, Lusco V, Cornell C, Ng-Mak DS, Shi R, Okerson T. Efficacy and safety of the adjustable gastric band - pooled interim analysis of the APEX and HERO studies at 48 weeks. Curr Med Res Opin. 2014 May;30(5):841-8. doi: 10.1185/03007995.2013.874992. Epub 2014 Jan 16.
- Fusco M, James S, Cornell C, Okerson T. Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study. Curr Med Res Opin. 2014 May;30(5):849-55. doi: 10.1185/03007995.2013.874991. Epub 2014 Jan 17.
- Shayani V, Voellinger D, Liu C, Cornell C, Okerson T. Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012 Jul;124(4):181-8. doi: 10.3810/pgm.2012.07.2561.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年6月1日
初级完成 (实际的)
2013年8月1日
研究完成 (实际的)
2013年11月1日
研究注册日期
首次提交
2007年7月11日
首先提交符合 QC 标准的
2007年7月12日
首次发布 (估计)
2007年7月13日
研究记录更新
最后更新发布 (估计)
2015年1月19日
上次提交的符合 QC 标准的更新
2015年1月15日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.