NL-OMON40379已完成3 期
A Randomized Controlled Multicenter Study of an Incisionless Operating Platform for Primary Obesity vs. Diet-Exercise alone: The MILEPOST Study - MILEPOST
SGI Medical, Inc0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age 20-60 years
- •* BMI of >30 and <40 with or without a co-morbid condition
- •* Patient has failed more conservative weight reduction alternatives such as supervised diet, exercise or behavior modification programs in the last year
- •* No significant weight change (+/- 5% of total body weight) in last 6 months
- •* American Society Anesthesiologists-PS score * 2 (Appendix III)
- •* Has not taken any prescription or over the counter weight loss medications for at least 6 months
- •* Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
- •* Subject is willing to cooperate with post-operative dietary recommendations and assessment tests
- •* Signed informed consent
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
- •* Severe Gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy
- •* Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
- •* Pancreatic insufficiency/disease
- •* Active peptic ulcer
- •* Pregnancy or plans of pregnancy in the next 12 months
- •* Present Corticosteroid Use
- •* History of inflammatory disease of GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
- •* History or present use of insulin or insulin derivatives for treatment of diabetes
- •* Type II Diabetes Mellitus (as defined by HgbA1c >6.5) for greater than 2 years at the time of enrollment
- •* Uncontrolled Type II DM (HgbA1c >7.0 at screening)
- •* Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
- •* Immunosuppression
- •* Portal hypertension and/or varices
- •* Active gastric ulcer disease
- •* Gastric outlet obstruction or stenosis
- •* Beck Depression Inventory (Short) Score *12 (see Appendix IV)
- •* Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST questionnaires or positive UA drug screen
- •* Severe disturbances in eating behavior (i.e. binge eating)
- •* Known presence of a significant depression, psychosis, or other mood or eating disorder
- •* Actively treated depression (except for stable treated depression for >1year and normal BDI and psych exam)
- •* Present or past history of psychosis or other mood or eating disorder
- •* Non-ambulatory or has significant impairment of mobility
- •* Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism
- •* Participating in another clinical study
- •* Is a first degree relative of investigator, or support staff involved in the study
- •* Employed by investigator or institution involved in the study or relative of same
- •* Subject is not able to provide written informed consent
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