Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome

Conditions
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Blind Loop Syndrome Postoperative, Candy Cane Syndrome

Intervention / Treatment
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* Device: MAGUS placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>The procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control. | Device: MAGUS placement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety related to the number of adverse event | 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 | 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 | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety : adverse event at mid and long term | All adverse events will be reported | After 3 months of implantation | 
| Safety : unplanned interventions | Number of unplanned interventions | Within the year following device placement | 
| Efficacy : patient's satisfaction with the therapy | 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 | 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 | 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 | 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 | Weight measurment in kg | At 14 and 28 days, and at 3 and 12 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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candy cane syndrome, therapeutic endoscopy, steptotomy