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

Not Applicable

Recruiting

• Conditions: Blind Loop Syndrome Postoperative; Candy Cane Syndrome
• Interventions: Device: MAGUS placement

• Registration Number: NCT05938439
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-10
• Study Start: 2023-08-01
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	MAGUS placement	The procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control.

Primary Outcome Measures

Name	Time	Method
Safety related to the number of adverse event	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
Performance on symptoms evolution	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)

Secondary Outcome Measures

Name	Time	Method
Safety : unplanned interventions	Within the year following device placement	Number of unplanned interventions
Efficacy : change in quality of life	At 28 days, 3 months and 12 months of follow-up	Short-Form-12 score. A higher score indicates a better quality of life
Efficacy : weight evolution	At 14 and 28 days, and at 3 and 12 months of follow-up	Weight measurment in kg
Safety : adverse event at mid and long term	After 3 months of implantation	All adverse events will be reported
Efficacy : dysphagia evolution	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.
Efficacy : patient's satisfaction with the therapy	At 3 and 12 months of follow-up	Scored by a visual analogue scale from 0 (= not satisfied at all) to 5 (=very satisfied)

Trial Locations

Locations (1)

Hôpital Universitaire de Bruxelles - Hôpital Erasme; 🇧🇪 Bruxelles, Belgium