Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies
研究概览
简要总结
This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe 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. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device.
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
- 是
入选标准
- •Presenting to University of North Carolina (UNC) for routine care upper endoscopy
- •Meet one of the following criteria:
- •Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
- •History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
- •Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus
- •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 Correctly Identified Negative (Non-Dysplastic) Biopsies
时间窗: day 1
Specificity of the a/LCI-OCT probe to detect absence of dysplasia as measured by percentage of correctly identified negative biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.
Percentage of Correctly Identified Positive (Dysplastic) Biopsies
时间窗: day 1
Sensitivity of the a/LCI-OCT probe to detect dysplasia as measured by percentage of correctly identified positive biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.
次要结局
- Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image(day 1)