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

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Disorder of Stomach and Duodenum
• Intervention / Treatment: Device: TIAN XIA; Device: KANG XIAN

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

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shangdong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shandong Branden Med.Device Co.,Ltd
• Investigators: Study Chair: Huixiong Xu, Dr., Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases
• Other Study ID Numbers: B202103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No