An interventional study of MAGUS placement in Blind Loop Syndrome Postoperative and Candy Cane Syndrome, sponsored by Erasme University Hospital. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Erasme University Hospital · Not applicable, Interventional, and Treatment
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.
11 studies on the registry are indexed under Blind Loop Syndrome; 4 are open to participants now.
This study's planned enrollment of 51 is close to the median of 48 across 10 interventional studies indexed under Blind Loop Syndrome.
Browse Blind Loop Syndrome studies →Erasme University Hospital is the lead sponsor of 181 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Coagulation disorders.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Safety related to the number of adverse event
All adverse events device or procedure related will be captured
Time frame: 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)
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
Performance on symptoms evolution
Evolution of nausea will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
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
Performance on symptoms evolution
Evolution of regurgitations/vomiting will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
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
Safety : adverse event at mid and long term
All adverse events will be reported
Time frame: After 3 months of implantation
Safety : unplanned interventions
Number of unplanned interventions
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Efficacy : weight evolution
Weight measurment in kg
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
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