Unspecified Disorder of Stomach and DuodenumNCT05676164
A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
A study testing KANG XIAN and TIAN XIA in people with Unspecified Disorder of Stomach and Duodenum, run by Shandong Branden Med.Device Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Disorder of Stomach and Duodenum
- What is being tested?
- KANG XIAN and TIAN XIA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2021to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Clinical 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.
Read the 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
- Being tested
- KANG XIAN, TIAN XIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KANG XIANDevice
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 XIADevice
The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Oral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD Receives: Device: TIAN XIA |
| Experimental group | Experimental | Oral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD Receives: Device: KANG XIAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour ± 0.5 hour after examination
Secondary outcomes (4)
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.
Measured: 1 hour ± 0.5 hour after examination
Stomach filling and peristaltic emptying
Stomach filling and peristaltic emptying represent the condition of stomach filling and peristaltic emptying observed by the study physician.
Measured: 1 hour ± 0.5 hour after examination
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.
Measured: 1 hour ± 0.5 hour after examination
Incidence of device adverse events
Device adverse events refer to device-related nausea, vomiting, abdominal pain, diarrhea, etc.
Measured: 48 hours ±12 hours after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start31 Mar 2021
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Disorder of Stomach and DuodenumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter, Prospective, Randomized Controlled Clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huixiong Xu, Dr., Study chair, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676164
- Sponsor's protocol ID
- B202103
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Clinical Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
- ClinicalTrials.gov ID
- NCT05676164
- Acronym / sponsor ID
- B202103
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Shandong Branden Med.Device Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Multicenter, Prospective, Randomized Controlled Clinical Study
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: TIAN XIAOral Contrast Agent for Sonography from Huzhou East Asia Medical Supplies Co., LTD |
| Experimental group | Experimental | Device: KANG XIANOral Contrast Agent for Sonography from Shandong branden Medical Device Co., LTD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KANG XIANThis 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. | Device | Experimental group |
| TIAN XIAThe products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam. | Device | Control group |
Primary outcome
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.
4 secondary outcomes
Anti-interference capability of product
Time frame: 1 hour ± 0.5 hour after examination
Stomach filling and peristaltic emptying
Time frame: 1 hour ± 0.5 hour after examination
Ease of operation
Time frame: 1 hour ± 0.5 hour after examination
Incidence of device adverse events
Time frame: 48 hours ±12 hours after examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huixiong Xu, Dr. study chair
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KANG XIAN and TIAN XIA in people with Unspecified Disorder of Stomach and Duodenum, run by Shandong Branden Med.Device Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonic display rate of stomach and duodenal bulb (time frame: 1 hour ± 0.5 hour after examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.