A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Ultrasonic display rate of stomach and duodenal bulb
研究概览
简要总结
The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.
详细描述
The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.
Participants will Ultrasound was administered with Oral Contrast Agent for Sonography and observed for 2 days.
The investigators will compare Oral Contrast Agent for Sonography produced by Huzhou East Asia Medical Supplies Co., LTD to see if the safety and efficacy of Oral Contrast Agent for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects whose physicians recommend oral gastrointestinal CEUS;
- •subjects aged 18-80 years;
- •The subject or guardian can understand the purpose of the study, voluntarily sign the informed consent, and agree to the clinical follow-up;
排除标准
- •Pregnant and lactating women;
- •Subjects with dysphagia;
- •Subjects suspected of gastric bleeding, gastrointestinal perforation, intestinal disorders or gastrointestinal obstruction;
- •Subjects who are expected to receive surgery within 60 hours;
- •Subjects who have received gastroscopy within 24 hours;
- •subjects deemed unsuitable for the study by the researcher;
- •Subjects who have participated in other drug or device clinical trials and have not completed the expected primary endpoint follow-up of the clinical trials in which they participated.
研究组 & 干预措施
Control group
Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD
干预措施: TIAN XIA (Device)
Experimental group
Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD
干预措施: KANG XIAN (Device)
结局指标
主要结局
Ultrasonic display rate of stomach and duodenal bulb
时间窗: 1 hour ± 0.5 hour after examination
The grade evaluation of the display effect will be determined by the total score of the gastric wall hierarchy and structure, the stomach and duodenal bulb morphology evaluation: 0-2 points for poor, 3-4 points for average, and 5-6 points for excellent. The total score of the display effect is greater than 2 points. After the end of the experiment, the sum of the number of cases with average and excellent imaging is divided by the total number of cases, and then multiplied by 100%, which is the ultrasonic display rate of the stomach and duodenal bulb.
次要结局
- Ease of operation(1 hour ± 0.5 hour after examination)
- Incidence of device adverse events(48 hours ±12 hours after examination)
- Stomach filling and peristaltic emptying(1 hour ± 0.5 hour after examination)
- Anti-interference capability of product(1 hour ± 0.5 hour after examination)