Assessment of a Consensus Driven Narrow Band Imaging Pattern Classification System in Barrett*s Esophagus - NBI Classification

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

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•Subjects shall be screened according to the following inclusion criteria. An answer of *no* to any inclusion criterion disqualifies a subject from participating in this study.
•* Patients age: * 18 years
•* Undergoing endoscopy for surveillance or endoscopic treatment of Barrett*s esophagus
•* Ability to take oral proton pump inhibitor
•* Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
•* Ability to discontinue ASA/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
•* Ability of provide written, informed consent and understands the responsibilities of trial participation

•Subjects shall be screened according to the following exclusion criteria. An answer of *yes* to any exclusion criterion disqualifies a subject from participating in this study.;* Esophageal stricture preventing passage of endoscope or catheter
•* Active erosive esophagitis
•* Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
•* History of esophageal varices or coagulopathy
•* Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
•* Evidence of esophageal varices during treatment endoscopy
•* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
•* The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the current study.
•* Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

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