NCT02518685已完成不适用
Endoscopic Treatment for Weight Reduction in Patients With Obesity Using the TransPyloric Shuttle® System: A Multicenter, Prospective, Randomized, Double-Blind, Sham-Controlled, Parallel-Design Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 18
- 主要终点
- Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
研究概览
简要总结
The purpose of this clinical research trial is to study safety and effectiveness of the TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered medically obese.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between the ages of 22 to 60
- •A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities
- •History of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program
- •< 5% change in body weight for at least 3 months
- •Negative pregnancy test, agree to be on birth control for the duration of participation
- •Informed consent
- •Willing and able to comply with study procedures
排除标准
- •Pregnancy or nursing
- •Hormonal or genetic cause for obesity
- •Prior history of any GI surgery or endoscopic intervention
- •Chronic use of medications likely to contribute to weight gain or prevent weight loss
- •Gastric or duodenal ulcers
- •Positive for H. pylori
- •History of severe dyspepsia
- •GI tract motility disorders
- •History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices
- •Diabetes treated with insulin
- •HbA1c >7.5%
- •Uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension
- •History of certain cardiac events
- •Localized or systemic infection
- •History of asthma likely to require systemic steroid therapy
- •Autoimmune connective tissue disorders or immunocompromised
- •History of malignancy except non-melanoma skin cancer
- •Continuous use of ulcerogenic medication
- •On anticoagulation or antiplatelet therapy
- •Use of weight-loss medication
- •In other weight-loss program
- •Unable to take proton pump inhibitor
- •Abnormal laboratory values or EKG
- •Inability to walk at least 0.8 kilometers per day
- •Planned surgical procedure that can impact the conduct of the study
- •Known allergy to any component materials in the TPSS
- •Smoker or user of nicotine product
- •Substance abuse
- •Severe, uncontrolled psychiatric illness
- •Recent inpatient psychiatric treatment
- •Moderate depression
- •Bulimia nervosa or binge eating disorder
- •Participation in another clinical study
- •Employee or family member of Sponsor or study staff
- •Have any endoscopic exclusion criteria
研究组 & 干预措施
TransPyloric Shuttle (TPS)
Experimental
TransPyloric Shuttle plus Lifestyle Counseling
干预措施: TransPyloric Shuttle (Device)
TransPyloric Shuttle (TPS)
Experimental
TransPyloric Shuttle plus Lifestyle Counseling
干预措施: Lifestyle Counseling (Behavioral)
Control
Sham Comparator
Sham procedure plus Lifestyle Counseling
干预措施: Sham procedure (Device)
Control
Sham Comparator
Sham procedure plus Lifestyle Counseling
干预措施: Lifestyle Counseling (Behavioral)
结局指标
主要结局
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
时间窗: 12 Months
The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
时间窗: 12 months
The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
次要结局
未报告次要终点
研究者
研究点 (18)
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