EsophagogastroduodenoscopyNCT03883035
Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System
A study of Esophagogastroduodenoscopy, run by Yanqing Li at 1 site in China.
Trial summary
The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Esophagogastroduodenoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 31 Oct 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing EGD examination with anaesthesia;
- patients able to give informed consent.
Who cannot join
- patients with the contraindications to EGD examination;
- patients with a prior EGD examination within 1 year before the trial;
- patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
- a history of upper gastrointestinal cancers;
- allergic to anaesthetic in previous medical history;
- patients refused to participate in the trial;
- the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms
The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.
Read the detailed description
In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.
- Conditions
- Esophagogastroduodenoscopy
- Being tested
- automatic quality-control system
- Keywords
- Esophagogastroduodenoscopy, gastric neoplasm, artificial intelligence, quality control
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic quality-control systemOther
Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.
| Study group | Role | What they receive |
|---|---|---|
| EAS-aided group | Experimental | esophagogastroduodenoscopy examination with the assistance of automatic quality-control system Receives: Other: automatic quality-control system |
| control group | No intervention | conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of gastric neoplasms
detection rate of gastric neoplasms in different groups
Measured: 8 months
Secondary outcomes (4)
mean number of gastric neoplasms detected
mean number of gastric neoplasms detected per procedure in different groups
Measured: 8 months
mean inspection completeness
inspection completeness per procedure in different groups
Measured: 8 months
mean inspection time
inspection time per procedure in different groups
Measured: 8 months
errors of EAS
errors of EAS in EAS-aided group
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Mar 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagogastroduodenoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883035
- Sponsor's protocol ID
- 2019SDU-QILU-02
- Status last verified
- Jan 2020
- First submitted
- 19 Mar 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms
- ClinicalTrials.gov ID
- NCT03883035
- Acronym / sponsor ID
- 2019SDU-QILU-02
- Conditions
- Esophagogastroduodenoscopy
- Keywords
- Esophagogastroduodenoscopy, gastric neoplasm, artificial intelligence, quality control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 20 Mar 2019 (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 aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.
Detailed description
In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EAS-aided group | Experimental | Other: automatic quality-control systemesophagogastroduodenoscopy examination with the assistance of automatic quality-control system |
| control group | No intervention | –conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing EGD examination with anaesthesia;
- patients able to give informed consent.
Key exclusion criteria (7 listed)
- patients with the contraindications to EGD examination;
- patients with a prior EGD examination within 1 year before the trial;
- patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
- a history of upper gastrointestinal cancers;
- allergic to anaesthetic in previous medical history;
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 |
|---|---|---|
| automatic quality-control systemAutomatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility. | Other | EAS-aided group |
Primary outcome
detection rate of gastric neoplasms
Time frame: 8 months
detection rate of gastric neoplasms in different groups
4 secondary outcomes
mean number of gastric neoplasms detected
Time frame: 8 months
mean inspection completeness
Time frame: 8 months
mean inspection time
Time frame: 8 months
errors of EAS
Time frame: 8 months
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 30 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Esophagogastroduodenoscopy, run by Yanqing Li 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 2 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 30 Jan 2020. 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?
detection rate of gastric neoplasms (time frame: 8 months). 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 30 Jan 2020.