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

NCT ID: NCT05938439

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2027-08-31

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.

Conditions

Blind Loop Syndrome Postoperative; Candy Cane Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

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

Group Type: EXPERIMENTAL

MAGUS placement

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brussel Medical Device Center (BMDC)

UNKNOWN

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Universitaire de Bruxelles - Hôpital Erasme

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Pauline Van Ouytsel

Role: CONTACT

pauline.vanouytsel@hubruxelles.be

025556531

Facility Contacts

Pauline Van Ouytsel, MSc.

Role: primary

pauline.vanouytsel@hubruxelles.be

025556531

Secretariat Gastroenterologie Medicale

Role: backup

SecMed.GastroMed@erasme.ulb.ac.be

025553712

References

Rio-Tinto R, Huberland F, Van Ouytsel P, Delattre C, Dugardeyn S, Cauche N, Delchambre A, Deviere J, Blero D. Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video). Gastrointest Endosc. 2022 Jun;95(6):1247-1253. doi: 10.1016/j.gie.2021.12.027. Epub 2022 Jan 1.

Reference Type: BACKGROUND

PMID: 34979115 (View on PubMed)

Other Identifiers

N2023/021

Identifier Type: -

Identifier Source: org_study_id