Diverticulum, EsophagealMAGUSNCT04480216
MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)
A study testing MAGUS in people with Diverticulum, Esophageal and Post Gastric Surgery Syndrome, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulum, Esophageal, Post Gastric Surgery Syndrome
- What is being tested?
- MAGUS
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Feb 2020to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study
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.
Read the 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.
- Being tested
- MAGUS
- Medical subject headings
- Diverticulum, Esophageal, Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGUSDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
Technical magnet placement success
ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)
Measured: Day 0
Type of evacuation of the device
natural or endoscopic
Measured: During 28 Days post-placement
Incidence of all adverse event
SAE during device placement
Measured: During 30 days post-placement
Secondary outcomes (8)
Number and type of AE after placement
Measured: 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)
Measured: Before treatment - Day 1 - Day 14 - Day 28 - Month 3
Number of unplanified interventions
Measured: During 3 months post-placement
Change of Eckardt and dysphagia score or GERD HRQL score
Measured: 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)
Measured: Day 14 - Day 28 - Month 3
Emptying rate of the diverticular structure
Measured: Month 3
Difference of height of the septum cut before and after the treatment
Measured: Month 3
Change of SF12 quality of life score
Measured: Before treatment - Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start19 Feb 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diverticulum, EsophagealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480216
- Sponsor's protocol ID
- P2019/643
- Acronym
- MAGUS
- Status last verified
- Dec 2021
- First submitted
- 27 Feb 2020
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34979115Huberland 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.
PubMed 34282579
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT04480216
- Acronym / sponsor ID
- MAGUS / P2019/643
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAGUSAn 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 | Device | – |
Primary outcome
Technical magnet placement success
Time frame: Day 0
ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)
Type of evacuation of the device
Time frame: During 28 Days post-placement
natural or endoscopic
Incidence of all adverse event
Time frame: During 30 days post-placement
SAE during device placement
8 secondary outcomes
Number and type of AE after placement
Time frame: During 3 month post placement
Patient's report of pain: visual analog scale
Time frame: Before treatment - Day 1 - Day 14 - Day 28 - Month 3
Number of unplanified interventions
Time frame: During 3 months post-placement
Change of Eckardt and dysphagia score or GERD HRQL score
Time frame: Before treatment - Day 1 - Day 14 - Day 28 - Month 3
Patient's satisfaction with the therapy: visual analogue scale
Time frame: Day 14 - Day 28 - Month 3
Emptying rate of the diverticular structure
Time frame: Month 3
Difference of height of the septum cut before and after the treatment
Time frame: Month 3
Change of SF12 quality of life score
Time frame: Before treatment - Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Derived from this study: PubMed 34979115Rio-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.
- Derived from this study: PubMed 34282579Huberland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGUS in people with Diverticulum, Esophageal and Post Gastric Surgery Syndrome, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical magnet placement success (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480216, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.