Qilu Hospital Of Shangdong University
Jinan, Shandong, China
NCT Number: NCT05676164
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Jinan, Shandong, China
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.
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.
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.
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.
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.
Time frame: 48 hours ±12 hours after examination
Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc.
Shandong Branden Med.Device Co.,Ltd
Industry
A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
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.