NL-OMON27008招募中不适用
Feasibility of real-time computer guided Volumetric Laser Endomicroscopy (VLE) targeted biopsies for improved detection of early Barrett's Neoplasia
Top Sector Life Sciences & Health: Health Holland & TKI, NinePoint Medical0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age > 18 years;
- •Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation.
- •Minimum Barrett’s extent (from Prague criteria) M = 2cm;
- •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);
排除标准
- •Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe;
- •Patients with known esophageal strictures, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe;
- •Contraindications for endomucosal resection (EMR) and/or obtaining biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices);
- •Patients within four weeks of receiving targeted forceps biopsies and/or EMR;
- •Unable to provide signed informed consent.
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