Unspecified Disorder of Stomach and Duodenum
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEKANG XIAN
This product is a liquid composed of silica, stabilizer, xylitol, flavoring agent and water. The pH value of the product is 5.0 \ 8.0, and the total heavy metal content (measured by Pb2+) is less than 10µg/ml.
DEVICETIAN XIA
The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.
Sponsors
Shandong Branden Med.Device Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Multicenter, Prospective, Randomized Controlled Clinical Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. subjects whose physicians recommend oral gastrointestinal CEUS; 2. subjects aged 18-80 years; 3. The subject or guardian can understand the purpose of the study, voluntarily sign the informed consent, and agree to the clinical follow-up;
Exclusion criteria
1. Pregnant and lactating women; 2. Subjects with dysphagia; 3. Subjects suspected of gastric bleeding, gastrointestinal perforation, intestinal disorders or gastrointestinal obstruction; 4. Subjects who are expected to receive surgery within 60 hours; 5. Subjects who have received gastroscopy within 24 hours; 6. subjects deemed unsuitable for the study by the researcher; 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonic display rate of stomach and duodenal bulb | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-interference capability of product | 1 hour ± 0.5 hour after examination | The satisfaction degree of the product's anti-interference ability refers to the satisfaction degree of the doctor's observation of the product in the stomach and duodenal bulb of the subject due to the product's homogeneity and the ability to eliminate gas artifacts. |
| Stomach filling and peristaltic emptying | 1 hour ± 0.5 hour after examination | Stomach filling and peristaltic emptying represent the condition of stomach filling and peristaltic emptying observed by the study physician. |
| Ease of operation | 1 hour ± 0.5 hour after examination | Ease of operation refers to the time required to prepare the device before use by the subject. The shorter the time, the better the ease of operation. |
| Incidence of device adverse events | 48 hours ±12 hours after examination | Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc. |
Countries
China
Outcome results
None listed