Back to resultsA Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
Primary Purpose
Unspecified Disorder of Stomach and Duodenum
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
KANG XIAN
TIAN XIA
Sponsored by
About this trial
This is an interventional diagnostic trial for Unspecified Disorder of Stomach and Duodenum
Eligibility Criteria
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.
Sites / Locations
- Qilu Hospital Of Shangdong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD
Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Stomach filling and peristaltic emptying
Stomach filling and peristaltic emptying represent the condition of stomach filling and peristaltic emptying observed by the study physician.
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.
Incidence of device adverse events
Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc.
Full Information
NCT ID
NCT05676164
First Posted
December 1, 2022
Last Updated
January 6, 2023
Sponsor
Shandong Branden Med.Device Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05676164
Brief Title
A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
Official Title
A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Branden Med.Device Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unspecified Disorder of Stomach and Duodenum
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Multicenter, Prospective, Randomized Controlled Clinical Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD
Intervention Type
Device
Intervention Name(s)
KANG XIAN
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TIAN XIA
Intervention Description
The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.
Primary Outcome Measure Information:
Title
Ultrasonic display rate of stomach and duodenal bulb
Description
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 Outcome Measure Information:
Title
Anti-interference capability of product
Description
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
Title
Stomach filling and peristaltic emptying
Description
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
Title
Ease of operation
Description
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
Title
Incidence of device adverse events
Description
Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc.
Time Frame
48 hours ±12 hours after examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huixiong Xu, Dr.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Qilu Hospital Of Shangdong University
City
Jinan
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
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