Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 9
- 主要终点
- Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
研究概览
简要总结
The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD.
The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed.
The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of GERD related symptoms for at least 2 years.
- •Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test.
- •History of daily intake of proton pump inhibitors (PPIs) for at least 6 months, with significant relief of symptoms (i.e., difference in GERD Health Related Quality of Life (GERD HRQL) scores on and off PPI > =6).
- •GERD-HRQL ≥20 off of PPI's
排除标准
- •Hiatal hernia > 3 cm or a paraesophageal hernia
- •Barrett's esophagus or grade IV esophagitis
- •Esophageal stricture, ring or web causing symptoms of dysphagia
- •Grade I Flap valve according Hill's classification
- •History of co-morbidity
研究组 & 干预措施
Medigus SRS Endoscopic Stapling System
Endoluminal fundoplication for the treatment of GERD
干预措施: Medigus SRS endoscopic stapling system (Device)
结局指标
主要结局
Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
时间窗: Six months
Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement \>= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval)
Serious Adverse Events (SAEs)
时间窗: 6 months
The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. "Treatment-related" events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients.
次要结局
- Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject(6 months)
- Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test(6 months)
研究者
Aviel Roy-Shapira, M.D.
Study director
Medigus Ltd