NCT01539850已完成不适用
Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Transgastric sensor site healing
研究概览
简要总结
The main objective of this study is to evaluate the LGL102 implant safety in obese to morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight changes will be also evaluated.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 - 60 years old at time of screening
- •BMI of 35 to 55 at time of screening
- •History of obesity ≥ 5 years
- •The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
- •Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
- •No significant weight loss (< 5%) within four months prior to enrollment as documented in the subject's medical record.
- •Successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment.
- •Glycosylated Hemoglobin; HbA1c ≤ 7.0 % at Visit 2 or historic value performed no more than 3 months prior to enrollment.
- •If taking anti-depressant medications, they must be stable for at least six months prior to enrollment
- •Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
- •Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
- •Able to provide voluntary informed consent
排除标准
- •Any prior bariatric surgery
- •Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
- •Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures
- •Use of anti-psychotic medications
- •Diagnosed with a eating disorder such as bulimia or binge eating
- •Obesity due to an endocrinopathy (e.g. Cushing disease)
- •Insulin therapy
- •GI disease such as hiatal hernia (> 5cm), gastroparesis, esophageal motility disorders or intractable constipation.
- •Any history of peptic ulcer disease within 5 years prior to enrollment
- •History of Barrett's esophagus
- •Women who are pregnant, lactating or anticipate becoming pregnant within 24 months
- •Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study.
- •Cardiac history that physician feels should exclude the patient from the study.
- •Use of another investigational device or agent in the 30 days prior to enrollment
- •A history of life-threatening disease within 5 years prior to enrollment
- •Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study
结局指标
主要结局
Transgastric sensor site healing
时间窗: 3 months
Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant.
次要结局
- Comorbid Conditions(3, 6 and 12 months)
- Excess weight loss(3, 6, and 12 months)
- Safety Evaluation(3, 6, and 12 months)
- Eating Behavior(3, 6 and 12 months)
- Quality of Life(3, 6 and 12 months)
研究者
研究点 (5)
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