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

Free University of Brussels (ULB)

Status

Enrolling

Conditions

Blind Loop Syndrome Postoperative

Candy Cane Syndrome

Treatments

Device: MAGUS placement

Study type

Interventional

Funder types

Other

Identifiers

NCT05938439

N2023/021

Details and patient eligibility

About

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.

Enrollment

51 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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