NCT01844921已完成不适用
High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
NinePoint Medical1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the number of patients achieving a VLE (volumetric laser endomicroscopy) image that includes stomach, gastro esophageal junction (GEJ) and esophagus.
研究概览
简要总结
This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE catheter to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Males and females over the age of 18 years.
- •Patients presenting for an EGD.
- •Ability to provide written, informed consent.
- •Females who are able to become pregnant, and are willing to take a pregnancy test.
排除标准
- •Patients on anticoagulation undergoing high risk procedures in accordance to American Society For Gastrointestinal Endoscopy (ASGE) guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
- •Patients with esophageal varices that preclude biopsies.
- •Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
- •Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
- •Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
- •Patients with known eosinophilic esophagitis.
- •Patients that 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 Willibrand's disease or other known platelet malfunction disorders.
结局指标
主要结局
The primary endpoint will be the number of patients achieving a VLE (volumetric laser endomicroscopy) image that includes stomach, gastro esophageal junction (GEJ) and esophagus.
时间窗: Day of procedure
Achieving a VLE image is defined as completing a full 6cm scan. This will be presented as a percentage of patients.
次要结局
- The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.(Day of procedure.)
研究者
研究点 (1)
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