Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Rate of successful completion of the requisite EUS examination
研究概览
简要总结
This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
详细描述
Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.
The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon.
排除标准
- •Age < 18 years.
- •Unable to obtain consent for the procedure from either the patient or LAR.
- •Intrauterine pregnancy.
结局指标
主要结局
Rate of successful completion of the requisite EUS examination
时间窗: 1 day
Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System.
次要结局
- Quality of EUS imaging(1 day)
- Diagnostic adequacy of procured specimen in cell block(7 days)
- Diagnostic accuracy of procured specimen(7 days)
- Rate of procedure-related adverse events(7 days)
- Ease of maneuverability of the device(1 day)
- Ease of performing tissue acquisition(1 day)
- Diagnostic adequacy of procured specimen on onsite evaluation(7 days)
- Procedure duration(1 day)
- Procedure costs(7 days)