MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS) (MAGUS)
Primary Purpose
Diverticulum, Esophageal, Post Gastric Surgery Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MAGUS
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulum, Esophageal
Eligibility Criteria
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.
Sites / Locations
- Hopital Erasme
Outcomes
Primary Outcome Measures
Technical magnet placement success
ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)
Type of evacuation of the device
natural or endoscopic
Incidence of all adverse event
SAE during device placement
Secondary Outcome Measures
Number and type of AE after placement
Patient's report of pain: visual analog scale
scored by a visual analog scale from 0 to 10 (0=no pain)
Number of unplanified interventions
Change of Eckardt and dysphagia score or GERD HRQL score
Patient's satisfaction with the therapy: visual analogue scale
scored by a visual analogue scale from 0 to 10 (10= fully satisfied)
Emptying rate of the diverticular structure
Difference of height of the septum cut before and after the treatment
Change of SF12 quality of life score
Full Information
NCT ID
NCT04480216
First Posted
February 27, 2020
Last Updated
December 7, 2021
Sponsor
Erasme University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04480216
Brief Title
MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)
Acronym
MAGUS
Official Title
MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, Candy cane syndrome This study aims to evaluating the safety of the feasability of this new device.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulum, Esophageal, Post Gastric Surgery Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
MAGUS
Intervention Description
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
Primary Outcome Measure Information:
Title
Technical magnet placement success
Description
ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)
Time Frame
Day 0
Title
Type of evacuation of the device
Description
natural or endoscopic
Time Frame
During 28 Days post-placement
Title
Incidence of all adverse event
Description
SAE during device placement
Time Frame
During 30 days post-placement
Secondary Outcome Measure Information:
Title
Number and type of AE after placement
Time Frame
During 3 month post placement
Title
Patient's report of pain: visual analog scale
Description
scored by a visual analog scale from 0 to 10 (0=no pain)
Time Frame
Before treatment - Day 1 - Day 14 - Day 28 - Month 3
Title
Number of unplanified interventions
Time Frame
During 3 months post-placement
Title
Change of Eckardt and dysphagia score or GERD HRQL score
Time Frame
Before treatment - Day 1 - Day 14 - Day 28 - Month 3
Title
Patient's satisfaction with the therapy: visual analogue scale
Description
scored by a visual analogue scale from 0 to 10 (10= fully satisfied)
Time Frame
Day 14 - Day 28 - Month 3
Title
Emptying rate of the diverticular structure
Time Frame
Month 3
Title
Difference of height of the septum cut before and after the treatment
Time Frame
Month 3
Title
Change of SF12 quality of life score
Time Frame
Before treatment - Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34979115
Citation
Rio-Tinto R, Huberland F, Van Ouytsel P, Delattre C, Dugardeyn S, Cauche N, Delchambre A, Deviere J, Blero D. Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video). Gastrointest Endosc. 2022 Jun;95(6):1247-1253. doi: 10.1016/j.gie.2021.12.027. Epub 2022 Jan 1.
Results Reference
derived
PubMed Identifier
34282579
Citation
Huberland F, Rio-Tinto R, Cauche N, Dugardeyn S, Delattre C, Sandersen C, Rocq L, van Ouytsel P, Delchambre A, Deviere J, Blero D. Magnets and a self-retractable wire for endoscopic septotomies: from concept to first-in-human use. Endoscopy. 2022 Jun;54(6):574-579. doi: 10.1055/a-1554-0976. Epub 2021 Oct 29.
Results Reference
derived
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MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)
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