MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The MAGUS device is an endoscopic procedure. Above standard of care monitoring, safety assessment of the procedure and device performance decreases the risk and unforeseen events.

Official Title
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MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study

Conditions
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Diverticulum, Esophageal, Post Gastric Surgery Syndrome

Intervention / Treatment
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* Device: MAGUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MAGUS|An upper endoscopy will be performed with the use of fluoroscopy. The MAGUS will be placed under fluoroscopy. The good positioning and the absence of any complications will be confirmed by gastroscopy. An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened. The patient will be kept overnight, with liquid food for 2 and mashed food up to 7 days post procedure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical magnet placement success | ability to deploy the MAGUS in satisfactory position across the septum (YES/NO) | Day 0 | 
| Type of evacuation of the device | natural or endoscopic | During 28 Days post-placement | 
| Incidence of all adverse event | SAE during device placement | During 30 days post-placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of AE after placement |  | During 3 month post placement | 
| Patient's report of pain: visual analog scale | scored by a visual analog scale from 0 to 10 (0=no pain) | Before treatment - Day 1 - Day 14 - Day 28 - Month 3 | 
| Number of unplanified interventions |  | During 3 months post-placement | 
| 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 | scored by a visual analogue scale from 0 to 10 (10= fully satisfied) | Day 14 - Day 28 - Month 3 | 
| Emptying rate of the diverticular structure |  | Month 3 | 
| 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 |