ReShape Intragastric Balloon for the Treatment of Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Total Weight Loss
研究概览
简要总结
A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within their labeled indications and as per their instructions for use. Enrolled patients will be followed for seven months. The patient will be prescribed a controlled diet, exercise and counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is male or female between the ages of 20 and 60 years of age.
- •The patient presents with a Body Mass Index (BMI) 30-40 kg/m
- •The patient is geographically stable and willing to return to the implant center for follow-up visits.
- •The patient has been adequately informed of risks and requirements and consents to his/her participation in the post market clinical study.
排除标准
- •The patient presents with 20 years > Age > 60 years.
- •The patient has a progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months.
- •The patient is a pregnant or lactating female.
- •The patient presents with a 30 kg/m2 > BMI > 40 kg/m
- •The patient has had previous abdominal surgery.
- •The patient has digestive tract disorders such as active peptic ulcers, bleeding disorders, esophageal varices, Crohn's disease.
- •The patient presents with psychiatric disorders.
- •The patient is participating in concomitant research studies of investigational products that would interfere with this study.
- •The patient has inability to return for follow-up assessments.
- •The patient is an alcohol or drug abuser.
结局指标
主要结局
Total Weight Loss
时间窗: baseline to 180 days
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
次要结局
未报告次要终点