NL-OMON47641已完成不适用
ext generation optical coherence tomography for improved detection of early Barrett*s neoplasia - VLE laser marking study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Age > 18 years;
- •- Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy, with or without dysplasia (low-grade or high-grade dysplasia or early adenocarcinoma);
- •- Signed informed consent.
排除标准
- •- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe;
- •- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe;
- •- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe;
- •- Contraindications for ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices);
- •- Previously treated dysplasia by either ER and/or ablation therapy;
- •- Unable to provide signed informed consent.
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