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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD |
|
| Experimental group | Experimental | Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KANG XIAN | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonic display rate of stomach and duodenal bulb | 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. | 1 hour ± 0.5 hour after examination |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-interference capability of product | 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. | 1 hour ± 0.5 hour after examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huixiong Xu, Dr. | Shanghai 10th People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital Of Shangdong University | Jinan | Shandong | China |
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A Multicenter, Prospective, Randomized Controlled Clinical Study
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| TIAN XIA | Device | The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam. |
|
| Stomach filling and peristaltic emptying | Stomach filling and peristaltic emptying represent the condition of stomach filling and peristaltic emptying observed by the study physician. | 1 hour ± 0.5 hour after examination |
| Ease of operation | 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. | 1 hour ± 0.5 hour after examination |
| Incidence of device adverse events | Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc. | 48 hours ±12 hours after examination |