Endoscopy, GastrointestinalNCT05851716
Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality
An observational study of Endoscopy, Gastrointestinal and Artificial Intelligence, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy, Gastrointestinal, Artificial Intelligence
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2023to 20 May 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is not limited. Patients aim to undergo screening, surveillance, and diagnosis upper gastrointestinal endoscopy will be accessed for eligibility.
Who may be able to join
- Aged 18 years
- Aim to undergo screening, surveillance, and diagnosis
- Undergo sedated EGD
- Able to read, understand, and sign informed consent
Who cannot join
- EGD contraindications
- Not suitable for sedated endoscopy after anaesthesia evaluation
- Biopsy contraindications
- Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
- Pregnancy
- Upper gastrointestinal surgery or residual stomach
- Not suitable for recruitment after investigator evaluation because of other high-risk conditions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Honggang Yu, +8613871281899, yuhonggang1968@163.com
About this study
Official title: A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy
The goal of this observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI assistance. Participants will undergo upper gastrointestinal endoscopy examination as routine. The junior endoscopists will draft the report with the assiatance of the AI system. And the senior and expert endoscopists will draft the report using the traditional reporting system without AI assistance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of reporting lesions
Calculation method = number of report lesions / total number of lesions x 100%
Measured: one month
Secondary outcomes (5)
Completeness of report drafting on lesion features
Calculation method = number of drafted features of lesions / total number of features required to be drafted x 100%
Measured: one month
Accuracy of report drafting on lesion features
Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
Measured: one month
Reporting time
The time that endoscopists draft reports
Measured: one month
Completeness of reporting lesions of AI system
Calculation method = number of report lesions / total number of lesions x 100%
Measured: one month
Accuracy of report drafting on lesion features of AI system
Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start21 Aug 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopy, GastrointestinalStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851716
- Sponsor's protocol ID
- EA-23-006
- Status last verified
- Aug 2023
- First submitted
- 30 Apr 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Single-center Observational Study to Evaluate the Clinical Effectiveness of an Intelligent Reporting System for the Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT05851716
- Acronym / sponsor ID
- EA-23-006
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 10 May 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 observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI assistance. Participants will undergo upper gastrointestinal endoscopy examination as routine. The junior endoscopists will draft the report with the assiatance of the AI system. And the senior and expert endoscopists will draft the report using the traditional reporting system without AI assistance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is not limited. Patients aim to undergo screening, surveillance, and diagnosis upper gastrointestinal endoscopy will be accessed for eligibility.
Key inclusion criteria (4 listed)
- Aged 18 years
- Aim to undergo screening, surveillance, and diagnosis
- Undergo sedated EGD
- Able to read, understand, and sign informed consent
Key exclusion criteria (7 listed)
- EGD contraindications
- Not suitable for sedated endoscopy after anaesthesia evaluation
- Biopsy contraindications
- Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completeness of reporting lesions
Time frame: one month
Calculation method = number of report lesions / total number of lesions x 100%
5 secondary outcomes
Completeness of report drafting on lesion features
Time frame: one month
Accuracy of report drafting on lesion features
Time frame: one month
Reporting time
Time frame: one month
Completeness of reporting lesions of AI system
Time frame: one month
Accuracy of report drafting on lesion features of AI system
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy, Gastrointestinal and Artificial Intelligence, run by Renmin Hospital of Wuhan University 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 4 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: status not confirmed, as of the sponsor's last update on 5 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, MD (+8613871281899, yuhonggang1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness of reporting lesions (time frame: one month). 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 5 Sep 2023.