NCT01503411已完成不适用
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)
NinePoint Medical2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1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
- 120
- 试验地点
- 2
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training implications for introducing this new imaging modality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Males and females over the age of 18 years.
- •Patients with either suspected BE presenting for endoscopy or patients with documented BE presenting for follow-up endoscopy likely to require a biopsy or patients presenting for endoscopy for non-BE related conditions other than esophageal varices.
- •Ability to provide written, informed consent.
- •Females who are able to become pregnant, 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 Nvision balloon guide sheath.
- •Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision balloon guide sheath.
- •Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the Nvision balloon guide sheath.
- •Patients with known eosinophilic esophagitis.
- •Patients that are pregnant.
- •Patients with a history of hemostasis disorders.
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: The research participants will be followed and evaluated for the duration of their VLE procedure, an expected average of 10 additional minutes beyond the standard EDG procedure.
The primary endpoint will be the number of subjects achieving completed VLE imaging studies at the time of EDG.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic CapsuleHealthyBarrett's EsophagusGastric Acid RefluxNCT02445014Massachusetts General Hospital3
撤回
不适用
High Resolution Optical Imaging of Barrett*s Esophagus Using N-Vision pVLE1) Barrett's oesophagus2) early oesophageal cancer1001799010017991NL-OMON37408Academisch Medisch Centrum50
已完成
不适用
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the BladderUrge Urinary IncontinenceNCT01619995University of Pittsburgh43
撤回
1 期
A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer PatientsHead and Neck CancerNCT01506427Siemens Molecular Imaging
Unknown
不适用
High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective StudyGastric NeoplasiaNCT02863965Shandong University200