A Pilot Study to Compare Anatomic, Physiologic, Metabolic and Weight Changes After Standard of Care Endoscopic Gastric Restrictive Bariatric Interventions vs. Standard of Care Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of participants with GERD before and after intervention
研究概览
简要总结
The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty.
详细描述
We want to better understand the mechanisms for weight loss by understanding the anatomic and physiologic changes that occur with gastric restrictive procedures for weight loss and to determine the differences in metabolic profile between the two restrictive procedures. We also want to identify the rate of Gastro Esophageal Reflux Disease (GERD) in patients undergoing gastric restrictive procedures for weight loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
- •Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
- •Both male and female subjects will be included in the study.
- •Subjects from any ethnic background will be included in the study.
- •Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).
- •Successfully complete the screening process.
- •Patients able to provide written informed consent on the IRB/EC-approved informed consent form.
- •Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.
- •Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.
排除标准
- •Pregnant or planning to become pregnant during period of study participation.
- •Female participants who are breast-feeding.
- •Severe Immunodeficiency.
- •Severe malnutrition.
- •The participant has life expectancy of less than 1 year due to other medical conditions.
结局指标
主要结局
Percentage of participants with GERD before and after intervention
时间窗: 1 years
Percentage of participants with GERD (\>6% abnormal esophageal acid exposure calculated via BRAVO pH monitoring for 96 hrs ) before and at 12 months after an endoscopic or surgical bariatric intervention
次要结局
- Compare gastric emptying after intervention(1 year)