Status:
COMPLETED
MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)
Lead Sponsor:
Erasme University Hospital
Conditions:
Diverticulum, Esophageal
Post Gastric Surgery Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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,...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04480216
Start Date
February 19 2020
End Date
September 15 2021
Last Update
December 8 2021
Active Locations (1)
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1
Hopital Erasme
Brussels, Belgium, 1070