NCT04095481Unknown不适用
Obalon Navigation/Touch System Post-Approval Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Esophageal Inflation
研究概览
简要总结
Post-approval study for the Obalon Navigation/Touch System (NTS)
详细描述
The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.
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
- 是
入选标准
- •Ages 22 years and older
- •Starting or current therapy BMI of 30.0-40.0 kg/m2
- •Commercially purchased the Obalon Balloon Device
排除标准
- •Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder of the esophagus.
- •Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
- •Known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.
- •Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
结局指标
主要结局
Esophageal Inflation
时间窗: Up to 20 Weeks
Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
System Success
时间窗: Up to 20 Weeks
Percentage of appropriate inflation in the stomach with the use of NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal
次要结局
未报告次要终点
研究者
研究点 (2)
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