NCT05049824已完成不适用
Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy
GI Windows, Inc.1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
详细描述
Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22-65 years at screening
- •Body mass index (BMI) ≥35 and ≤50
- •Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.
- •Weight stable over 3-month period
- •Negative H. pylori breath test
- •Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
- •If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
- •Able to understand and sign informed consent documents.
排除标准
- •Known or suspected allergy to nickel or titanium or nitinol
- •Contraindication to general anesthesia
- •Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series
- •Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- •Clinically significant findings during screening endoscopy at target region for compression anastomosis
- •Uncontrolled hypertension
- •Pre-existing severe comorbid cardio-respiratory disease
- •History of type 1 diabetes or poorly controlled type 2 diabetes
- •Abnormal liver biochemistry
- •History of chronic gastrointestinal disease
- •Specific genetic or hormonal cause of obesity
- •Recent tobacco/nicotine product cessation (within 3 months prior)
结局指标
主要结局
Weight Loss
时间窗: 12 Months
1. Weight loss measured as a percent of total body weight (TBW)
次要结局
- Change in blood pressure(12 Months)
- Change in Absolute Weight Loss(12 Months)
- Percent responders(12 Months)
- Change in BMI(12 Months)
- Change in HbA1c(12 Months)
- Change in serum lipids(12 Months)
- Excess weight loss(12 Months)
- Change in fasting glucose(12 Months)
研究者
研究点 (1)
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