NCT03434834已完成不适用
Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
Duke University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年9月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
研究概览
简要总结
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to University of North Carolina (UNC) for routine care upper endoscopy
- •Meet one of the following criteria:
- •Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
- •History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
- •Aged 18 to 80
- •Able to read, comprehend, and understand the informed consent document.
排除标准
- •Prior esophageal surgery (uncomplicated nissen fundoplication OK)
- •Pregnant women
- •Unable to provide written informed consent
结局指标
主要结局
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
时间窗: at baseline
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
时间窗: at baseline
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
次要结局
- Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image(at baseline)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
a/LCI-OCT Pilot in EsophagusBarrett EsophagusNCT04392167Duke University37
已完成
不适用
The Use of a OCT Probe in Assessment of Endoscopic and Surgical Resection Specimen of Gastrointestinal TractGastrointestinal NeoplasmsNCT04670718Chinese University of Hong Kong8
尚未招募
不适用
Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal ImagingHealthyNCT02441777Massachusetts General Hospital20
暂停
不适用
Ultra-High Resolution Optical Coherence Tomography in Detecting Micrometer Sized Early Stage Pancreatic Cancer in Participants With Pancreatic CancerPancreatic CarcinomaPancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-TypeNCT03711890Ohio State University Comprehensive Cancer Center75
已完成
不适用
CEI Van Outreach Screening StudyGlaucomaMacular DiseaseKeratoconusNCT01510392Oregon Health and Science University118