Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Performance on symptoms evolution
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Interventional
The procedure consists in Medical Device (MAGUS) placement by endoscopy under general anesthesia with fluoroscopic control.
干预措施: MAGUS placement (Device)
结局指标
主要结局
Performance on symptoms evolution
时间窗: 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)
Safety related to the number of adverse event
时间窗: 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
次要结局
- Safety : adverse event at mid and long term(After 3 months of implantation)
- Efficacy : dysphagia evolution(At 14 and 28 days, and at 3 and 12 months of follow-up)
- Safety : unplanned interventions(Within the year following device placement)
- Efficacy : change in quality of life(At 28 days, 3 months and 12 months of follow-up)
- Efficacy : weight evolution(At 14 and 28 days, and at 3 and 12 months of follow-up)
- Efficacy : patient's satisfaction with the therapy(At 3 and 12 months of follow-up)