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

Shandong Branden Med.Device Co.,Ltd280 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

280

Conditions

Unspecified Disorder of Stomach and Duodenum

Interventions

KANG XIANDEVICE

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.

TIAN XIADEVICE

The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Qilu Hospital Of Shangdong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 1 hour ± 0.5 hour after examination

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 48 hours ±12 hours after examination

Data from ClinicalTrials.gov

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