Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05851885
Other study ID # EA-23-007
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2023
Est. completion date May 20, 2024

Study information

Verified date April 2023
Source Renmin Hospital of Wuhan University
Contact Honggang Yu, MD
Phone +8613871281899
Email yuhonggang1968@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 125
Est. completion date May 20, 2024
Est. primary completion date April 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Aged 18 years 2. Aim to undergo screening, surveillance, and diagnosis 3. Undergo sedated EGD 4. Able to read, understand, and sign informed consent Exclusion Criteria: 1. EGD contraindications 2. Not suitable for sedated endoscopy after anaesthesia evaluation 3. Biopsy contraindications 4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD) 5. Pregnancy 6. Upper gastrointestinal surgery or residual stomach 7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
AI-based reporting system
AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Renmin Hospital of Wuhan University

Outcome

Type Measure Description Time frame Safety issue
Primary Completeness of reporting lesions Calculation method = number of report lesions / total number of lesions x 100% one month
Secondary 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% one month
Secondary Accuracy of report drafting on lesion features Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100% one month
Secondary Reporting time The time that endoscopists draft reports one month
Secondary Completeness of reporting lesions of AI system Calculation method = number of report lesions / total number of lesions x 100% one month
Secondary 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% one month
Secondary 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. one month
See also
  Status Clinical Trial Phase
Completed NCT04589078 - Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
Completed NCT03857438 - Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania
Completed NCT04735055 - Artificial Intelligence Prediction for the Severity of Acute Pancreatitis
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Not yet recruiting NCT04337229 - Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques N/A
Completed NCT05687318 - A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment N/A
Recruiting NCT06051682 - Optimization of the Diagnosis of Bone Fractures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor. N/A
Not yet recruiting NCT06039917 - Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions N/A
Not yet recruiting NCT06362629 - AI App for Management of Atopic Dermatitis N/A
Recruiting NCT06164002 - A I in the Prediction of Clinical Performance, Marginal Fit and Fracture Resistance of Vertical Versus Horizontal Margin Designs Fabricated With 2 Ceramic Materials N/A
Recruiting NCT06059378 - Real-life Implementation of an AI-based Optical Diagnosis N/A
Completed NCT05517889 - Repeatability and Stability of Healthy Skin Features on OCT
Completed NCT05006092 - Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE) N/A
Completed NCT04816981 - AI-EBUS-Elastography for LN Staging N/A
Recruiting NCT04535466 - Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics
Enrolling by invitation NCT04719117 - Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
Completed NCT04399590 - Comparing the Number of False Activations Between Two Artificial Intelligence CADe Systems: the NOISE Study
Recruiting NCT04126265 - Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps N/A
Recruiting NCT06255808 - Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
Recruiting NCT04131530 - Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence