Skip to content

A Prospective, Single-Center, Diagnostic Study: Accuracy of an Artificial Intelligence System in the Diagnosis and Risk Stratification of Atrophic Gastritis

A Prospective, Single-Center, Diagnostic Study: Accuracy of an Artificial Intelligence System in the Diagnosis and Risk Stratification of Atrophic Gastritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044881
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-03-30
Completion date
Unknown
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Gastritis

Interventions

Gold Standard:Biopsy was performed on the five sites of antrum greater and lesser curvature, incisura lesser curvature, and middle corpus greater and lesser curvature. Pathological results were used a
Index test:EndoAngel

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male or female aged 18 years or above; 2.Gastroscopy is needed to further define the characteristics of digestive tract diseases; 3.Helicobacter pylori (H.P) negative, including uninfected and eradicated persons; 4.Be able to read, understand and sign informed consent; 5.The investigator believes that the subject can understand the process of the clinical study and is willing and able to complete all the study procedures and follow-up visits and cooperate with the study procedures.

Exclusion criteria

Exclusion criteria: 1.Participated in other clinical trials, signed the informed consent and was in the follow-up period of other clinical trials; 2.Has participated in a clinical trial of the drug and is in the washout period of the experimental drug or control drug; 3.Pregnant or lactating women; 4.Past history of malignant tumor; 5.Have used antithrombotic drugs within the last two weeks; 6.History of esophageal and gastric varices; 7.History of upper gastrointestinal bleeding; 8.Esophageal stenosis caused by various causes; 9.Subjects with residual stomach; 10.Previous medical history of allergy to pre-used anesthetic drugs; 11.Subject was deemed unsuitable for painless gastroscopy by the investigator; 12.High risk diseases or other special conditions that the investigator considers unsuitable for the subject to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of GA/IM;Accuracy of disease risk assessment;

Secondary

MeasureTime frame
GA/IM diagnostic sensitivity, specificity, positive predictive value, negative predictive value, ROC;Sensitivity, specificity, positive predictive value, negative predictive value, ROC of gastric cancer risk assessment;Recognition accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC;The detection rate;

Countries

China

Contacts

Public ContactYu Honggang

Renmin Hospital of Wuhan University

yuhonggang1968@163.com+86 13871281899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026