Using a new device to treat Candy Cane Syndrome
Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
This study is testing a new device to see if it can help people with Candy Cane Syndrome feel better by relieving their symptoms without needing major surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Erasme University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05938439 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the MAgnetic Gastrointestinal Universal Septotome (MAGUS) for treating Candy Cane Syndrome, a complication that can arise after gastric surgery. The device is implanted endoscopically and aims to alleviate symptoms by creating a passage in the affected blind loop of the intestine. The study focuses on patients experiencing symptoms such as pain, nausea, and vomiting, which are associated with this condition. The goal is to provide a less invasive alternative to traditional surgical revision methods.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Candy Cane Syndrome who experience at least one associated symptom such as pain, nausea, or vomiting.
Not a fit: Patients with certain conditions such as refractory stenosis, coagulation disorders, or those who have undergone recent abdominal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option for patients suffering from Candy Cane Syndrome, potentially improving their quality of life.
How similar studies have performed: Previous studies using similar endoscopic techniques have shown promise, but this specific approach with the MAGUS device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- Hôpital Universitaire de Bruxelles - Hôpital Erasme — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Pauline Van Ouytsel
- Email: pauline.vanouytsel@hubruxelles.be
- Phone: 025556531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.