Endoscopy, GastrointestinalNCT05851885
Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System
A study testing AI-based reporting system in people with Endoscopy, Gastrointestinal and Artificial Intelligence, run by Renmin Hospital of Wuhan University.
Trial summary
The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endoscopy, Gastrointestinal, Artificial Intelligence
- What is being tested?
- AI-based reporting system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2023to 20 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
No sites are listed yet.
About this study
Official title: A Single-center, Prospective, Parallel Randomized Controlled Study Evaluating the Clinical Effectiveness of an Intelligent Graphic Report System for Upper Gastrointestinal Endoscopy
The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.
- Being tested
- AI-based reporting system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based reporting systemDiagnostic test
AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Physicians draft EGD reports with the assistance of the AI-based reporting system. Receives: Diagnostic Test: AI-based reporting system |
| Control group | No intervention | Physicians use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination. |
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 (6)
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
Physician satisfaction survey
Use 5-point Likert scale to assess physician satisfaction, acceptance, and trust in using the intelligent graphic report system to draft endoscopic reports.
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 start20 May 2023 (estimated)
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Honggang Yu, MD, Principal investigator, Wuhan University Renmin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851885
- Sponsor's protocol ID
- EA-23-007
- Status last verified
- Apr 2023
- First submitted
- 30 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Parallel Randomized Controlled Study Evaluating the Clinical Effectiveness of an Intelligent Graphic Report System for Upper Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT05851885
- Acronym / sponsor ID
- EA-23-007
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- 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 objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: AI-based reporting systemPhysicians draft EGD reports with the assistance of the AI-based reporting system. |
| Control group | No intervention | –Physicians use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based reporting systemAI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy. | Diagnostic test | Experimental group |
Primary outcome
Completeness of reporting lesions
Time frame: one month
Calculation method = number of report lesions / total number of lesions x 100%
6 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
Physician satisfaction survey
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 10 May 2023.
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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.
Honggang Yu, MD principal investigator
Wuhan University Renmin Hospital
Questions about this trial
What is this clinical trial studying?
A study testing AI-based reporting system in people with Endoscopy, Gastrointestinal and Artificial Intelligence, run by Renmin Hospital of Wuhan University.
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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 10 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.