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Completed

NCT Number: NCT05676164

A 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital Of Shangdong University

Jinan, Shandong, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

TIAN XIA

Device

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

Primary outcomes

  1. Ultrasonic display rate of stomach and duodenal bulb

    Time frame: 1 hour ± 0.5 hour after examination

    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.

Secondary outcomes

  1. Anti-interference capability of product

    Time frame: 1 hour ± 0.5 hour after examination

    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.

  2. Stomach filling and peristaltic emptying

    Time frame: 1 hour ± 0.5 hour after examination

    Stomach filling and peristaltic emptying represent the condition of stomach filling and peristaltic emptying observed by the study physician.

  3. Ease of operation

    Time frame: 1 hour ± 0.5 hour after examination

    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.

  4. Incidence of device adverse events

    Time frame: 48 hours ±12 hours after examination

    Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc.

Sponsors and collaborators

Lead sponsor

Shandong Branden Med.Device Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.