MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Type of evacuation of the device
研究概览
简要总结
A novel magnetic device, called MAgnetic Gastrointestinal Universal Septotome (MAGUS) was designed to improve the Treatment of diverticulum of the esophagus, Pseudo-diverticulum of the upper GI tract, Candy cane syndrome This study aims to evaluating the safety of the feasability of this new device.
详细描述
In this study, the investigators aim at treating different pathological conditions, resulting in the appearance of a septum separating a healthy pathway and a pathological pouch. Food then stagnate in this pouch and results in different symptoms including dysphagia, pain and/or regurgitation or postprandial dysrhythmia.
Esophageal diverticula consists in the apparition of a pouch (diverticulum) alongside the esophagus. Some post-surgical conditions can result in the appearance of pseudo-diverticulum or afferent limb that transforms into a large pouch. One example is the candy cane syndrome, being an afferent loop syndrome post gastrectomy or post Roux-en-Y Gastric Bypass, were the afferent limb becomes a structure similar to a large diverticulum.
All those pathological conditions could be solved by the marsupialization of those (pseudo-)diverticulum. For several years, Zenker's diverticula (pharyngo-esophageal diverticulum) have been treated endoscopically using this technique, providing good clinical results. However, it is difficult to go further than the pharynx with this technique, since it needs specific semi-rigid tools and a stable cutting position. Hence, for further septa of the GI tract, the classic treatment is thoracoscopy and thoracotomy or laparoscopy and laparotomy, depending on the site. Those highly invasive procedures have a significant mortality and morbidity rate respectively of more than 5% and 20% and are liked to different complications including abdominal pain, port site wound infections, intraabdominal collection or anastomosis ulcer.
The MAGUS device consists of a flexible catheter preloaded with a magnetic device, made of two magnets linked by a wire. Each magnet is attached to the catheter and can be dropped separately from this catheter. The magnetic device aims to create an anastomosis by means of compression, using magnetic force and a retractable wire pulling system. For a given septum, the magnets are placed on either sides of the bottom of it. The retractable wire goes then from one another, passing on top of the septum. Both creates compression necrosis. This process induces eventually a cutting of the septum.
Once the cutting is performed, the magnets migrate and are expelled through natural ways.
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
- •Age 18 years or older.
- •Patient has got evaluable symptoms (dysphagia, regurgitation, pain, weight loss, halitosis or others) associated with one of the following pathology:
- •Diverticulum of the esophagus;
- •A pseudo-diverticulum of the upper GI tract;
- •Candy cane syndrome;
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Refractory stenosis of the UGI proximal to the septum;
- •Septum height smaller than 2,5 cm or higher than 6 cm (check through CT scan, Barium Swallow or other imaging method);
- •Coagulation disorders;
- •Previous implantation of a magnetic-sensitive medical device (including active electronic implant, metallic stent, …);
- •Dysphagia related to motility disorder;
- •Planned MRI in the following month (30 days) of intervention.
- •Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety;
- •Patient went through a surgery less than 8 weeks before implantation of the magnets;
- •Currently enrolled in another clinical trial.
结局指标
主要结局
Type of evacuation of the device
时间窗: During 28 Days post-placement
natural or endoscopic
Technical magnet placement success
时间窗: Day 0
ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)
Incidence of all adverse event
时间窗: During 30 days post-placement
SAE during device placement
次要结局
- Number and type of AE after placement(During 3 month post placement)
- Patient's report of pain: visual analog scale(Before treatment - Day 1 - Day 14 - Day 28 - Month 3)
- Number of unplanified interventions(During 3 months post-placement)
- Difference of height of the septum cut before and after the treatment(Month 3)
- Change of SF12 quality of life score(Before treatment - Month 3)
- Change of Eckardt and dysphagia score or GERD HRQL score(Before treatment - Day 1 - Day 14 - Day 28 - Month 3)
- Patient's satisfaction with the therapy: visual analogue scale(Day 14 - Day 28 - Month 3)
- Emptying rate of the diverticular structure(Month 3)