<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04480216</url>
  </required_header>
  <id_info>
    <org_study_id>P2019/643</org_study_id>
    <nct_id>NCT04480216</nct_id>
  </id_info>
  <brief_title>MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study (MAGUS)</brief_title>
  <acronym>MAGUS</acronym>
  <official_title>MAgnetic Gastrointestinal Universal Septotome: a Safety and Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasme University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A novel magnetic device, called MAgnetic Gastrointestinal Universal Septotome (MAGUS) was&#xD;
      designed to improve the Treatment of diverticulum of the esophagus, Pseudo-diverticulum of&#xD;
      the upper GI tract, Candy cane syndrome This study aims to evaluating the safety of the&#xD;
      feasability of this new device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators aim at treating different pathological conditions, resulting&#xD;
      in the appearance of a septum separating a healthy pathway and a pathological pouch. Food&#xD;
      then stagnate in this pouch and results in different symptoms including dysphagia, pain&#xD;
      and/or regurgitation or postprandial dysrhythmia.&#xD;
&#xD;
      Esophageal diverticula consists in the apparition of a pouch (diverticulum) alongside the&#xD;
      esophagus. Some post-surgical conditions can result in the appearance of pseudo-diverticulum&#xD;
      or afferent limb that transforms into a large pouch. One example is the candy cane syndrome,&#xD;
      being an afferent loop syndrome post gastrectomy or post Roux-en-Y Gastric Bypass, were the&#xD;
      afferent limb becomes a structure similar to a large diverticulum.&#xD;
&#xD;
      All those pathological conditions could be solved by the marsupialization of those&#xD;
      (pseudo-)diverticulum. For several years, Zenker's diverticula (pharyngo-esophageal&#xD;
      diverticulum) have been treated endoscopically using this technique, providing good clinical&#xD;
      results. However, it is difficult to go further than the pharynx with this technique, since&#xD;
      it needs specific semi-rigid tools and a stable cutting position. Hence, for further septa of&#xD;
      the GI tract, the classic treatment is thoracoscopy and thoracotomy or laparoscopy and&#xD;
      laparotomy, depending on the site. Those highly invasive procedures have a significant&#xD;
      mortality and morbidity rate respectively of more than 5% and 20% and are liked to different&#xD;
      complications including abdominal pain, port site wound infections, intraabdominal collection&#xD;
      or anastomosis ulcer.&#xD;
&#xD;
      The MAGUS device consists of a flexible catheter preloaded with a magnetic device, made of&#xD;
      two magnets linked by a wire. Each magnet is attached to the catheter and can be dropped&#xD;
      separately from this catheter. The magnetic device aims to create an anastomosis by means of&#xD;
      compression, using magnetic force and a retractable wire pulling system. For a given septum,&#xD;
      the magnets are placed on either sides of the bottom of it. The retractable wire goes then&#xD;
      from one another, passing on top of the septum. Both creates compression necrosis. This&#xD;
      process induces eventually a cutting of the septum.&#xD;
&#xD;
      Once the cutting is performed, the magnets migrate and are expelled through natural ways.&#xD;
&#xD;
      The MAGUS device is an endoscopic procedure. Above standard of care monitoring, safety&#xD;
      assessment of the procedure and device performance decreases the risk and unforeseen events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2020</start_date>
  <completion_date type="Actual">September 15, 2021</completion_date>
  <primary_completion_date type="Actual">September 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical magnet placement success</measure>
    <time_frame>Day 0</time_frame>
    <description>ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Type of evacuation of the device</measure>
    <time_frame>During 28 Days post-placement</time_frame>
    <description>natural or endoscopic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of all adverse event</measure>
    <time_frame>During 30 days post-placement</time_frame>
    <description>SAE during device placement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and type of AE after placement</measure>
    <time_frame>During 3 month post placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's report of pain: visual analog scale</measure>
    <time_frame>Before treatment - Day 1 - Day 14 - Day 28 - Month 3</time_frame>
    <description>scored by a visual analog scale from 0 to 10 (0=no pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unplanified interventions</measure>
    <time_frame>During 3 months post-placement</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Eckardt and dysphagia score or GERD HRQL score</measure>
    <time_frame>Before treatment - Day 1 - Day 14 - Day 28 - Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction with the therapy: visual analogue scale</measure>
    <time_frame>Day 14 - Day 28 - Month 3</time_frame>
    <description>scored by a visual analogue scale from 0 to 10 (10= fully satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emptying rate of the diverticular structure</measure>
    <time_frame>Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of height of the septum cut before and after the treatment</measure>
    <time_frame>Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of SF12 quality of life score</measure>
    <time_frame>Before treatment - Month 3</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">16</enrollment>
  <condition>Diverticulum, Esophageal</condition>
  <condition>Post Gastric Surgery Syndrome</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MAGUS</intervention_name>
    <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.&#xD;
An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened.&#xD;
The patient will be kept overnight, with liquid food for 2 and mashed food up to 7 days post procedure</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Patient has got evaluable symptoms (dysphagia, regurgitation, pain, weight loss,&#xD;
             halitosis or others) associated with one of the following pathology:&#xD;
&#xD;
               1. Diverticulum of the esophagus;&#xD;
&#xD;
               2. A pseudo-diverticulum of the upper GI tract;&#xD;
&#xD;
               3. Candy cane syndrome;&#xD;
&#xD;
          -  Willing and able to comply with the study procedures and provide written informed&#xD;
             consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refractory stenosis of the UGI proximal to the septum;&#xD;
&#xD;
          -  Septum height smaller than 2,5 cm or higher than 6 cm (check through CT scan, Barium&#xD;
             Swallow or other imaging method);&#xD;
&#xD;
          -  Coagulation disorders;&#xD;
&#xD;
          -  Previous implantation of a magnetic-sensitive medical device (including active&#xD;
             electronic implant, metallic stent, …);&#xD;
&#xD;
          -  Dysphagia related to motility disorder;&#xD;
&#xD;
          -  Planned MRI in the following month (30 days) of intervention.&#xD;
&#xD;
          -  Concurrent medical condition that would affect the investigator's ability to evaluate&#xD;
             the patient's condition or could compromise patient safety;&#xD;
&#xD;
          -  Patient went through a surgery less than 8 weeks before implantation of the magnets;&#xD;
&#xD;
          -  Currently enrolled in another clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hopital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>February 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diverticulum</mesh_term>
    <mesh_term>Diverticulum, Esophageal</mesh_term>
    <mesh_term>Postgastrectomy Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04480216
org study id: P2019/643
nct id: NCT04480216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical magnet placement success
time frame: Day 0
description: ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)
measure: Type of evacuation of the device
time frame: During 28 Days post-placement
description: natural or endoscopic
measure: Incidence of all adverse event
time frame: During 30 days post-placement
description: SAE during device placement
measure: Number and type of AE after placement
time frame: During 3 month post placement
measure: Patient's report of pain: visual analog scale
time frame: Before treatment - Day 1 - Day 14 - Day 28 - Month 3
description: scored by a visual analog scale from 0 to 10 (0=no pain)
measure: Number of unplanified interventions
time frame: During 3 months post-placement
measure: Change of Eckardt and dysphagia score or GERD HRQL score
time frame: Before treatment - Day 1 - Day 14 - Day 28 - Month 3
measure: Patient's satisfaction with the therapy: visual analogue scale
time frame: Day 14 - Day 28 - Month 3
description: scored by a visual analogue scale from 0 to 10 (10= fully satisfied)
measure: Emptying rate of the diverticular structure
time frame: Month 3
measure: Difference of height of the septum cut before and after the treatment
time frame: Month 3
measure: Change of SF12 quality of life score
time frame: Before treatment - Month 3
intervention type: Device
intervention name: MAGUS
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
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Diverticulum
mesh term: Diverticulum, Esophageal
mesh term: Postgastrectomy Syndromes
sharing ipd: No