Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Ability to Acquire Intestinal Images in an Unsedated Infant
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility of using the transnasal endomicroscopy (TNE) platform, using intestinal potential difference (IPD) and microbiome brush to evaluate the intestine of unsedated infants.
详细描述
A total of fifteen (15) subjects, infants 6 months of age to 48 months of age will be enrolled in this study.
While the subject is awake and unseated, a catheter with optical coherence tomography (OCT) imaging technology will be introduced transnasally. Images will be acquired while the tube is moved through the subject's GI tract. After imaging is complete, accessory device(s) may be threaded through the catheter to collect samples of the gut microbiome and/or measure intestinal potential difference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 to 48 month old infants that can follow fasting requirements
排除标准
- •Any infant under 6kg of weight since this is the minimum weight for 6.5 F nasogastric (NG) tube
- •Any infant whose nasal passage cannot reasonably accommodate a 6.5 French nasoduodenal catheter.
- •Any infants with absolute or relative contraindications to transnasal tubes:
- •severe midface trauma and recent nasal, throat, or esophageal surgery.
- •Esophageal varices, esophageal stricture, and alkaline ingestion
- •Congenital anatomical defects affecting the gastrointestinal tract, most specifically cleft lip and/or cleft palate.
- •Any infant with absolute or relative contraindication to a duodenal biopsy:
- •post bone marrow transplant
- •coagulation abnormalities
结局指标
主要结局
Ability to Acquire Intestinal Images in an Unsedated Infant
时间窗: Approximate 90 minute study visit
Can the technology successfully collect images of the small intestine in an unseated infant?
Ability for Unsedated Infant Subjects to Tolerate the Device
时间窗: Approximate 90 minute study visit
Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?
Ability to Visualize Features of the Small Intestine in Unsedated Infants.
时间窗: Approximate 90 minute study visit
Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants?
Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples
时间窗: Approximate 90 minute study visit
Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?
次要结局
- Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants(Approximate 90 minute study visit)
- Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants(Approximate 90 minute study visit)
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital