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A prospective, single-arm, objective performance criteria study evaluating the accuracy of ENDOANGEL in the diagnosis of early gastric cancer

A prospective, single-arm, objective performance criteria study evaluating the accuracy of ENDOANGEL in the diagnosis of early gastric cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035116
Enrollment
Unknown
Registered
2020-08-01
Start date
2020-08-03
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Early Gastric Cancer

Interventions

Gold Standard:Pathological diagnosis, imaging diagnosis, doctor diagnosis, and clinical history or death report.
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Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Men or women over 18 years old (included); 2) Needing a magnifying gastroscopy to further clarify the characteristics of the digestive tract disease; 3) Painless gastroscopy patients; 4) Ability to read, understand and sign informed consent; 5) The researcher 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) Have participated in clinical trials of drugs and have been in the elution period of experimental drugs or control drugs; 2) Drug or alcohol abuse or psychological disorder in the last 5 years; 3) Pregnant or nursing women; 4) History of previous gastric surgery or diagnosed with residual stomach; 5) Previous history of allergy to anaesthetic drug; 6) Previous history of allergy to spasmolytic ; 7) The researchers conclude that the subjects are not suitable for painless gastroscopy; 8) The investigators believe that subjects are not eligible for high-risk disease or other special conditions in clinical trials.

Design outcomes

Primary

MeasureTime frame
ENDOANGEL's accuracy in M-NBI/BLI;

Secondary

MeasureTime frame
ENDOANGEL's sensitivity in M-NBI/BLI;ENDOANGEL's specificity in M-NBI/BLI;Endoscopists' accuracy, sensitivity and specificity in M-NBI/BLI;

Countries

China

Contacts

Public ContactYu Honggang

Department of Gastroenterology, Renmin Hospital of Wuhan University

yuhonggang1968@163.com+86 13871281899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026