Feasibility of Computer guided Volumetric Laser Endomicroscopy (VLE) Targeted Biopsies for Improved Detection of Early Barrett*s Neoplasia - VLE CAD pilot study

Academisch Medisch Centrum0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•* 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);

•* 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.

发起方