跳至主要内容
临床试验/NCT02859883
NCT02859883已完成不适用

Evaluation of Oesogastroduodenoscopy With Vision to 245 ° (Full Spectrum Endoscopy) to View the Main Disc and Accessory

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2015年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Efficacy

研究概览

简要总结

The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions .

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

入选标准

  • Patient eligible to any upper gastrointestinal endoscopy diagnostic

排除标准

  • History of duodenal or gastric surgery

结局指标

主要结局

Efficacy

时间窗: 1 day

Visualization of minor and major papilla Absence of necessity to change endoscope for viewing and / or for biopsies

次要结局

  • Number of patient with treatment-related serious adverse events(5 day)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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