Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care.
Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.
详细描述
All procedures, barring research activities such as consenting and data collection from Electronic Health Record , will be either clinically indicated and/or standard of care. Subject data will be collected and recorded in a registry which will allow for the prospective review and collection of clinical data related to Endoscopic Sleeve Gastroplasty for safety and efficacy assessment.
Study duration: At least 12 standard of care visits up to 1 year for each subject.
Standard of care follow up visits for Endoscopic Sleeve Gastroplasty are usually 2 weeks, 3 months, 6 months and 12 months post procedure with the physician and 8 follow-up visits over the year with a dietitian. No additional research related visits will be requested. All data will be collected from Electronic Health Record.
Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Able to comprehend and provided written informed consent
- •Willing to comply with the substantial lifelong dietary restrictions required by the procedure
- •History of failure with non-surgical weight-loss methods
- •Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
- •Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
排除标准
- •Below 18 years of age
- •Prohibitive anesthetic risk
结局指标
主要结局
Weight loss
时间窗: 8/1/2018 and 8/1/2023
Percentage of total and excess weight loss at 30 days, 3 months, 6 months and 12 months after procedure.
次要结局
- Documentation of safety(8/1/2018 and 8/1/2023)