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

Shandong Branden Med.Device

Status

Completed

Conditions

Unspecified Disorder of Stomach and Duodenum

Treatments

Device: TIAN XIA

Device: KANG XIAN

Study type

Interventional

Funder types

Industry

Identifiers

NCT05676164

B202103

Details and patient eligibility

About

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.

Full 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

Enrollment

280 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.