NCT05938439 Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
| NCT ID | NCT05938439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasme University Hospital |
| Condition | Blind Loop Syndrome Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 51 participants in total. It began in 2023-08-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05938439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Blind Loop Syndrome Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05938439 currently recruiting?
Yes, NCT05938439 is actively recruiting participants. Contact the research team at pauline.vanouytsel@hubruxelles.be for enrollment information.
Where is the NCT05938439 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05938439 clinical trial?
NCT05938439 is sponsored by Erasme University Hospital. The trial plans to enroll 51 participants.