NCT02366039已完成不适用
Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia
研究概览
简要总结
This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology
详细描述
To assess the ability of pVLE to visualize subsurface architecture of EMR tissue, as compared to histology in both in vivo and ex vivo imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females over the age of 18 years.
- •Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
- •Ability to provide written, informed consent.
- •Females must be willing to take a pregnancy test if still capable of bearing a child.
排除标准
- •Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
- •Patients with esophageal varices that preclude biopsies.
- •Presence of an esophageal mass/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
- •Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
- •Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
- •Patients with known eosinophilic esophagitis.
- •Patients who are pregnant.
- •Patients with a history of hemostasis disorders*.
- •Patients on anticoagulation undergoing low risk procedures are not excluded. ** Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willebrand's disease or other known platelet malfunction disorders.
结局指标
主要结局
distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia
时间窗: at time of endoscopic mucosal resection
We will assess descriptive and diagnostic performance (accuracy, sensitivity, specificity, positive and negative predictive values) of the Nvision pVLE device in visualizing dysplasia as compared to standard histopathology
次要结局
未报告次要终点
研究者
Cadman Leggett
Principal Investigator
Mayo Clinic
研究点 (1)
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