Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome (MAGUS-CCS)

November 16, 2023 updated by: Erasme University Hospital

Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%.

A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS.

This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years.

After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is diagnosed with candy cane syndrome based on clinical and endoscopic and/or radiologic assessment
  • Patient has at least one of this 3 symptoms associated to CCS: pain, nausea, vomiting, regurgitation
  • Patient agrees and is 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 cm or higher than 8 cm

  • 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
  • Condition that could compromise patient safety
  • Patient who went through an abdominal surgery less than 8 weeks before implantation of the magnets
  • Patient pregnant, breastfeeding or incapacitated
  • Patient currently enrolled in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional
The procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control.
Device: MAGUS placement

An upper endoscopy will be performed with the use of fluoroscopy under general anaesthesia with orotracheal intubation. The delivery system will be placed over a guidewire, under fluoroscopy. The main steps are the following:

  • Placement through the endoscope of a soft guidewire through the upper GI tract;
  • Insertion of the MAGUS system on the guidewire;
  • Advancement of the MAGUS system until proximal magnet reach the top of the septum;
  • Release and placement of the proximal magnet at the bottom of the septum, pouch side;
  • Meeting of the distal and proximal magnet on both sides of the septum, by pulling on the delivery system;
  • Release of the distal magnet and activate the retractable wire;
  • Insure that wire is not blocked and unblocked it if applicable.

Endoscopy and contrast injection will be performed before and after placement to ensure the correct positioning of the magnets.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety related to the number of adverse event
Time Frame: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up
All adverse events device or procedure related will be captured
During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up
Performance on symptoms evolution
Time Frame: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Evolution of pain will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Performance on symptoms evolution
Time Frame: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Evolution of nausea will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Performance on symptoms evolution
Time Frame: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up
Evolution of regurgitations/vomiting will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety : adverse event at mid and long term
Time Frame: After 3 months of implantation
All adverse events will be reported
After 3 months of implantation
Safety : unplanned interventions
Time Frame: Within the year following device placement
Number of unplanned interventions
Within the year following device placement
Efficacy : patient's satisfaction with the therapy
Time Frame: At 3 and 12 months of follow-up
Scored by a visual analogue scale from 0 (= not satisfied at all) to 5 (=very satisfied)
At 3 and 12 months of follow-up
Efficacy : change in quality of life
Time Frame: At 28 days, 3 months and 12 months of follow-up
Short-Form-12 score. A higher score indicates a better quality of life
At 28 days, 3 months and 12 months of follow-up
Efficacy : dysphagia evolution
Time Frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Eckart score from 0 to 12. A higher score indicates more severe pathology.
At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : dysphagia evolution
Time Frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Dysphagia score from 1 to 5. A higher score indicates more severe pathology.
At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : weight evolution
Time Frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Weight measurment in kg
At 14 and 28 days, and at 3 and 12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasme University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brussel Medical Device Center (BMDC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N2023/021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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