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

NCT05676164 | Completed DMC

• 1 other identifier: B202103
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Disorder of Stomach and Duodenum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Anti-interference capability of product

  1 hour ± 0.5 hour after examination

• Stomach filling and peristaltic emptying

  1 hour ± 0.5 hour after examination

• Ease of operation

  1 hour ± 0.5 hour after examination

• Incidence of device adverse events

  48 hours ±12 hours after examination

Study Arms (2)

Control group

ACTIVE COMPARATOR

Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD

Device: TIAN XIA

Experimental group

EXPERIMENTAL

Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD

Device: KANG XIAN

Interventions

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.

Experimental group

TIAN XIA DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead

Study Sites (1)

Qilu Hospital Of Shangdong University

Jinan, Shandong, China

Location

Study Officials

• Huixiong Xu, Dr.

  Shanghai 10th People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Multicenter, Prospective, Randomized Controlled Clinical Study

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: January 9, 2023
• Study Start: March 31, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: January 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)