Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in Celiac Disease in Children, Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging
研究概览
简要总结
The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease.
详细描述
The Optical Frequency Domain Imaging(OFDI) catheter will be used in conjunction with a standard pediatric endoscope. The endoscopist will introduce the OFDI imaging catheter through the biopsy channel of the endoscope already in place. The catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. The catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. Once the OFDI probe is in place, OFDI imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm.
It is expected that the total experimental procedure including the insertion of the OFDI catheter, OFDI imaging, and removal of the catheter will add approximately 10 minutes to the total length of the 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7 years and above undergoing upper endoscopy for evaluation of celiac disease
- •Clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease
- •Parents/guardian available to sign informed consent
排除标准
- •Patients with a history of hemostasis disorders
- •Use of Nonsteroidal anti-inflammatory drugs(NSAIDS) within ten days preceding initiation of the study
- •Use of any oral anticoagulation medication within one month preceding initiation of the study
- •Any known blood coagulation disorder
研究组 & 干预措施
MGH OFDI imaging
OFDI imaging
干预措施: MGH OFDI Imaging (Device)
结局指标
主要结局
Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging
时间窗: during imaging session
OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions. In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo
次要结局
未报告次要终点
研究者
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital