MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)
Nyckelord
Abstrakt
Beskrivning
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.
Datum
Senast verifierad: | 06/30/2020 |
Först skickat: | 02/26/2020 |
Beräknad anmälan inlämnad: | 07/15/2020 |
Först publicerad: | 07/20/2020 |
Senaste uppdatering skickad: | 07/15/2020 |
Senaste uppdatering publicerad: | 07/20/2020 |
Faktiskt startdatum för studien: | 02/18/2020 |
Uppskattat primärt slutdatum: | 03/31/2023 |
Beräknat slutfört datum: | 03/31/2023 |
Tillstånd eller sjukdom
Intervention / behandling
Device: MAGUS
Fas
Urvalskriterier
Åldrar berättigade till studier | 18 Years Till 18 Years |
Kön som är berättigade till studier | All |
Accepterar friska volontärer | Ja |
Kriterier | 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: 1. Diverticulum of the esophagus; 2. A pseudo-diverticulum of the upper GI tract; 3. 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. |
Resultat
Primära resultatåtgärder
1. Technical magnet placement success [Day 0]
2. Type of evacuation of the device [During 28 Days post-placement]
3. Incidence of all adverse event [During 30 days post-placement]
Sekundära resultatåtgärder
1. Number and type of AE after placement [During 3 month post placement]
2. Patient's report of pain: visual analog scale [Before treatment - Day 1 - Day 14 - Day 28 - Month 3]
3. Number of unplanified interventions [During 3 months post-placement]
4. Change of Eckardt and dysphagia score or GERD HRQL score [Before treatment - Day 1 - Day 14 - Day 28 - Month 3]
5. Patient's satisfaction with the therapy: visual analogue scale [Day 14 - Day 28 - Month 3]
6. Emptying rate of the diverticular structure [Month 3]
7. Difference of height of the septum cut before and after the treatment [Month 3]
8. Change of SF12 quality of life score [Before treatment - Month 3]