A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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

Official Title
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A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography

Conditions
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Unspecified Disorder of Stomach and Duodenum

Intervention / Treatment
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* Device: KANG XIAN
* Device: TIAN XIA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Multicenter, Prospective, Randomized Controlled Clinical Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD | Device: TIAN XIA<br>* The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.<br>|
| Experimental: Experimental group<br>Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD | Device: KANG XIAN<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |