An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- To Evaluate the Incidence of All Adverse Events at Various Time Points.
研究概览
简要总结
Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)
详细描述
The purpose of this feasibility study is to collect preliminary performance and safety information and develop procedural optimization for the Torax Medical Inc. Magnetic Esophageal Sphincter device (MES) in reinforcement of Esophageal Sphincter function to treat Gastroesophageal Reflux Disease (GERD). The information from this study will be used to support the design and conduct of an expanded clinical trial.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, < 85 years, life expectancy > 3yrs.
- •Documented history of GERD symptoms such as heartburn and/or regurgitation.
- •On daily PPI treatment for at least 3-months.
- •Responsive to PPI treatment.
- •GERD symptoms, in absence of PPI therapy (minimum 10 days).
- •Ambulatory Esophageal pH < 4 for ≥ 5% time or pH < 4 for ≥ 3% time in supine position.
- •Patient is a surgical candidate.
- •Patient is willing and able to cooperate with follow-up examinations.
- •Patient has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes (HIPAA).
排除标准
- •The procedure is an emergency procedure.
- •Patient is currently being treated with another investigational drug or investigational device.
- •Patient has had prior gastric or esophageal surgery.
- •Patient has had any previous endoscopic intervention for GERD
- •Patient has suspected or confirmed esophageal or gastric cancer.
- •Patient has any size paraesophageal hiatal hernia or sliding hiatal hernia ≥3cm. (Investigator to identify and record type of hiatal hernia at the time of assessment (i.e. para-esophageal, sliding)).
- •Patient's esophageal motility is less than 35 mmHg peristaltic amplitude on wet swallows or > 30% failed (non-propulsive) peristaltic sequences.
- •Patient has esophagitis - Grade B, C, D (LA Classification).
- •Patient has Barretts Esophagus.
- •Patient has BMI >
- •Patient has symptoms of dysphagia or indications of dysphagia from barium esophagram.
- •Patient has Scleroderma and/or Achalasia.
- •Patient has an esophageal stricture or gross esophageal anatomic abnormalities (obstructive lesions, etc.).
- •Patient has an electrical implant or metallic, abdominal implant(s).
- •Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
- •Patient is pregnant or nursing, or plans to become pregnant.
- •Patient has a psychiatric disorder.
结局指标
主要结局
To Evaluate the Incidence of All Adverse Events at Various Time Points.
时间窗: 5 years
To Monitor the Improvement of GERD Symptoms.
时间窗: 5 years
Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms
次要结局
未报告次要终点