NCT04480216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

February 27, 2020

Last Update Submit

December 7, 2021

Conditions

Diverticulum, EsophagealPost Gastric Surgery Syndrome

Outcome Measures

Primary Outcomes (3)

  • Technical magnet placement success

    ability to deploy the MAGUS in satisfactory position across the septum (YES/NO)

    Day 0

  • Type of evacuation of the device

    natural or endoscopic

    During 28 Days post-placement

  • Incidence of all adverse event

    SAE during device placement

    During 30 days post-placement

Secondary Outcomes (8)

  • Number and type of AE after placement

    During 3 month post placement

  • Patient's report of pain: visual analog scale

    Before treatment - Day 1 - Day 14 - Day 28 - Month 3

  • Number of unplanified interventions

    During 3 months post-placement

  • Change of Eckardt and dysphagia score or GERD HRQL score

    Before treatment - Day 1 - Day 14 - Day 28 - Month 3

  • Patient's satisfaction with the therapy: visual analogue scale

    Day 14 - Day 28 - Month 3

  • +3 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme

Brussels, 1070, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 34979115DERIVED

  • 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.

    PMID: 34282579DERIVED

MeSH Terms

Conditions

Diverticulum, EsophagealDumping Syndrome

Condition Hierarchy (Ancestors)

DiverticulumDiverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostgastrectomy SyndromesStomach DiseasesPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

July 21, 2020

Study Start

February 19, 2020

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

December 8, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)