A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD
试验速览
- 阶段
- 不适用
- 发起方
- Medigus Ltd
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Frequency of device and procedure related adverse events
研究概览
简要总结
This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.
详细描述
The registry evaluates the MUSE System which creates a transoral anterior fundoplication for the treatment of GERD. The system enables the operator to staple the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The procedure is performed transorally under general anesthesia. The procedural result is anatomically and functionally similar to standard anterior fundoplication (Dor-Thal operation). The staples are standard, 4.8mm titanium surgical staples. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching medications at the time of the procedure are essential.
The study population will be primarily adults aged 18-70 years selected by the investigators based on SAGES guidelines for fundoplication and consideration of the indications and contraindications listed in the device Instructions for Use (IFU).
Follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally follow the guidelines for Laparoscopic Fundoplication published by SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD
- •Positive acid exposure test or endoscopic evidence of esophagitis AND
- •Inadequate symptom control or
- •Patient preference from surgery over medications or
- •Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)
排除标准
- •Significant co-morbidity (for example, American Society of Anesthesiologists Grade 3 or higher)
- •BMI >35 or <20
- •No response to proton pump inhibitors
- •Grade IV esophagitis
- •Hiatal hernia >3 cm
- •Irreducible hernia of any size
- •Gastric outlet obstruction
- •Short esophagus
- •Esophageal diverticula, strictures or varices
- •Esophageal motility disorders
结局指标
主要结局
Frequency of device and procedure related adverse events
时间窗: 30 days post procedure
Device or procedure-related adverse events and serious adverse events will be evaluated for onset, frequency and duration. The primary safety assessment time point will be within 30 days of the procedure.
次要结局
- Procedure Durability(Up to 3 years post procedure)