Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of serious adverse events
研究概览
简要总结
To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.
详细描述
In 15%-25% of diagnosed inflammatory bowel disease (IBD) cases, disease manifestation begins before the age of 18. IBD primary includes Crohn's disease (CD) and ulcerative colitis (UC). Studies have shown that the current incidence of pediatric IBD ranges from 4-7 cases per 100,000, worldwide. Early and accurate diagnosis of IBD is important for correct prognosis, course of disease, therapeutic decisions and follow-up. Complete diagnostic work-up is key to proper diagnosis in patients.Early diagnosis of IBD and differentiation between UC and CD can be difficult in children. The major issues that face pediatric IBD today include accurate disease classification, unknown extent of disease, complete bowel visualization, inability to reach depth of findings, and biopsy retrieval for diagnostic work-up.
The NaviAid™ AB device presents a new and unique concept that helps overcome these short comings of IBD diagnosis and treatment. Through repetitive inflation and deflation of the NaviAid™ AB, the endoscope can be swiftly advanced deep into the small bowel via the proximal or distal route, allowing for complete visualization of the small bowel and easy biopsy sampling for histopathology. As a result, subsequent diagnoses can influence proper action for further treatment and therapy for the patient. Although many studies have reported on the safety and efficacy of balloon enteroscopy in adults with IBD, further investigation of the value of balloon enteroscopy in pediatric patients with known or suspected IBD is still required.
This is a single-center, non-randomized open-label study intended to evaluate the safety and efficacy of the NaviAid™ AB device during small bowel enteroscopy in children with known or suspected IBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages 8-18
- •Patients with known or suspected IBD (including Crohn's disease or ulcerative colitis).
- •The patient/parent of patient must understand and provide written consent for the procedure.
排除标准
- •Subjects with known coagulation disorder;
- •Subjects with known hernia;
- •Subjects with suspected stricture or stenosis;
- •Any patient condition deemed too risky for the study by the investigator
- •Subjects who are currently enrolled in another clinical investigation.
研究组 & 干预措施
NaviAid™ AB
NaviAid™ AB device procedure
干预措施: NaviAid™ AB (Device)
结局指标
主要结局
Number of serious adverse events
时间窗: Subjects will be followed up with in 72 hours following the procedure.
Patients will be followed up during the study period (3 hours) and once again 48-72 hours following the procedure. At both times, serious adverse events will be assessed.
次要结局
- Classification of disease(Up to 14 days (histology))
- Number of findings(Up to 14 days (histology))
- Depth of insertion(During procedure)
- Ease of use(During procedure)
- Extension of disease(Up to 14 days (histology))
- Procedural times(During procedure)