NCT02927665Unknown不适用
A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 186
- 试验地点
- 14
- 主要终点
- Safety of ReShape Dual Balloon Treatment
研究概览
简要总结
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.
详细描述
The ReShape Post Approval Study is a post-approval, multicenter, single arm, open label clinical study intended to collect valid scientific evidence regarding the safety and efficacy of the ReShape Dual Balloon as an adjunct to diet and exercise in the treatment of BMI 30-40 subjects with one or more obesity-related comorbid conditions in a commercial clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 22 and older
- •Baseline BMI 30 - 40
- •Failed weight reduction with diet and exercise alone
- •One or more obesity-related comorbid conditions
- •If female of child bearing potential, willing to avoid pregnancy during course of treatment
排除标准
- •Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
- •Prior open or laparoscopic bariatric surgery.
- •Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- •Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
- •A gastric mass.
- •A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
- •A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
- •Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
- •Severe coagulopathy
- •Hepatic insufficiency or cirrhosis
- •Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
- •Alcoholism or drug addiction.
- •Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
- •Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
- •Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- •Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
- •Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo placement of the device.
- •Patients who are pregnant or breast-feeding.
- •Significant endoscopic abnormalities immediately prior to device insertion.
结局指标
主要结局
Safety of ReShape Dual Balloon Treatment
时间窗: 24 weeks
Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs
次要结局
未报告次要终点
研究者
研究点 (14)
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