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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Hôpital Universitaire de Bruxelles - Hôpital Erasme
RECRUITING
Brussels
Contact Information
Primary
Pauline Van Ouytsel
pauline.vanouytsel@hubruxelles.be
025556531
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 51
Treatments
Experimental: Interventional
The procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control.
Sponsors
Collaborators: Brussel Medical Device Center (BMDC)
Leads: Erasme University Hospital

This content was sourced from clinicaltrials.gov

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