NCT01771276已完成不适用
Evaluating Impact of ULTIMATE Number of G-CATH EZ- Suture Anchors Placed Endoscopically on Motility, Metabolism, Satiety, and Weight Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity
USGI Medical2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年6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
- 10
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.
详细描述
This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a BMI of >30 and <40
- •Male or female ≥21 yrs. of age and < 60 yrs. of age at time of enrollment
- •Patient has had no significant weight change (+/- 5% of total body weight) in last 6 months but has been able to lose significant weight in the past with diet and exercise.
- •Is a reasonable candidate for general anesthesia
- •Agrees not to have any additional weight loss interventional procedures or liposuction for at least 18 months following study enrollment and agrees not to take any prescription or over the counter weight loss medications for at least 1 year.
- •Physically and mentally able to comply with the visit schedule, ancillary testing, and behavior modification (diet and exercise) required for the study and agrees to study commitment requirements
- •Had successful completion of the pre-screening, nutritional and educational programs and psychological assessment supporting that the subject is an appropriate bariatric surgical candidate
排除标准
- •History of (or intra-operative evidence of) bariatric, gastric or esophageal surgery
- •Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
- •Moderate to severe Gastro-esophageal reflux disease (GERD)
- •Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
- •Known GI motility disorder or pancreatic insufficiency/disease
- •Intra-operative Exclusion: Active peptic ulcer or hiatal hernia >3cm
- •Pregnancy.
- •Present Corticosteroid Use
- •History of inflammatory disease of GI tract
- •Severe coagulopathies, hepatic insufficiency or cirrhosis
- •History or present use of insulin or insulin derivatives for treatment of diabetes
- •Had Type II Diabetes Mellitus (as defined by HgbA1c >6.0) for greater than 2 years at the time of enrollment
- •Uncontrolled Type II DM (HgbA1c >7.0 at screening)
- •Patient has quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
- •Patient has a history of drug or alcohol abuse or actively abusing either
- •Patient is presently being treated with medication for depression, psychosis, or other mood or eating disorder
- •Non-ambulatory or has significant impairment of mobility
- •Works for, or is first degree relative of investigator, study institution, or support staff involved in the study.
- •Known hormonal or genetic cause for obesity
- •Participating in another clinical study
- •Patient is on medications known to impact GI motility or gut hormones that cannot be discontinued prior to nuclear testing
- •Have work hours, family obligations or transportation issues that could interfere with patient returning for all scheduled evaluations, tests and nutritional counseling.
- •Lives >60 kilometers from investigator site.
- •Patient is not able to provide written informed consent
结局指标
主要结局
Weight Loss
时间窗: 18 months
Weight loss will be monitored and recorded on a monthly basis for up to 18 months post POSE with the proportion of subjects achieving ≥25% excess weight loss (EWL) at 12 months (Met Life criteria)being the primary efficacy endpoint
次要结局
- Gastric emptying(Immediately Pre-procedure, & 2 & 6 months post procedure)
研究者
研究点 (2)
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