Hôpital Universitaire de Bruxelles - Hôpital Erasme
Brussels, 1070, Belgium
Location status: Recruiting
Location contact
Jacques Devière
PRINCIPAL_INVESTIGATOR
Pauline Van Ouytsel, MSc.
CONTACT
Secretariat Gastroenterologie Medicale
CONTACT
Recruiting
NCT Number: NCT05938439
Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
MAGUS placement
DeviceAn 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.
Primary outcomes
-
Safety related to the number of adverse event
Time frame: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up
All adverse events device or procedure related will be captured
-
Performance on symptoms evolution
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
Evolution of pain will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
-
Performance on symptoms evolution
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
Evolution of nausea will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
-
Performance on symptoms evolution
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
Evolution of regurgitations/vomiting will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Secondary outcomes
-
Safety : adverse event at mid and long term
Time frame: After 3 months of implantation
All adverse events will be reported
-
Safety : unplanned interventions
Time frame: Within the year following device placement
Number of unplanned interventions
-
Efficacy : patient's satisfaction with the therapy
Time frame: At 3 and 12 months of follow-up
Scored by a visual analogue scale from 0 (= not satisfied at all) to 5 (=very satisfied)
-
Efficacy : change in quality of life
Time frame: At 28 days, 3 months and 12 months of follow-up
Short-Form-12 score. A higher score indicates a better quality of life
-
Efficacy : dysphagia evolution
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Eckart score from 0 to 12. A higher score indicates more severe pathology.
-
Efficacy : dysphagia evolution
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Dysphagia score from 1 to 5. A higher score indicates more severe pathology.
-
Efficacy : weight evolution
Time frame: At 14 and 28 days, and at 3 and 12 months of follow-up
Weight measurment in kg
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Erasme University Hospital
Other
Collaborators
- Brussel Medical Device Center (BMDC)
Registry information
Acronym: MAGUS-CCS
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 10, 2023
- Registry last updated
- Nov 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.