Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
研究概览
简要总结
This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •RYGB patient with weight regain age 18-90
- •Scheduled for an endoscopy
- •Willingness and ability to provide informed consent
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •1. History of prior endoscopies with complications
结局指标
主要结局
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
时间窗: 8 months
次要结局
- Additional procedure time needed to incorporate use of Napoleon(8 months)
- Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition(8 months)
- Proportion of cases with adverse events or unanticipated problems related to use of Napoleon(8 months)
- Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device(8 months)