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A prospective, randomized, single-blind, parallel-controlled, multicenter study for evaluating the effectiveness and safety of EndoAngel in improving the quality of gastroscopy

A prospective, randomized, single-blind, parallel-controlled, multicenter study for evaluating the effectiveness and safety of EndoAngel in improving the quality of gastroscopy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018403
Enrollment
Unknown
Registered
2018-09-15
Start date
2018-11-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Gastric cancer

Interventions

Gold Standard:Pathological diagnosis, imaging diagnosis, and clinical history or death report
Index test:Artificial&#32
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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 the age of 18; 2) Need a 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 investigators believe that the subject understands the flow of the clinical study and is willing and able to complete all of the research procedures and follow-up visits in conjunction with the research process.

Exclusion criteria

Exclusion criteria: 1) Has participated in other clinical trials, signed informed consent and was followed during other clinical trials; 2) Have participated in the drug clinical trial and during the elution period of the test drug or control drug; 3) Drug or alcohol abuse or psychological disorder in the past 5 years; 4) Pregnant or lactating women; 5) A history of previous gastric surgery or a patient diagnosed with residual stomach; 6) History of anesthesia allergy; 7) History of antispasmodic allergy; 8) The investigators believe that the subject is not suitable for painless gastroscopy; 9) The investigators believe that subjects are not eligible for high-risk disease or other special conditions in clinical trials.

Design outcomes

Primary

MeasureTime frame
the Number of Blind Spots;

Secondary

MeasureTime frame
Inspection time;Performance of EndoAngel on predicting EGC;the percent of patients being overlooked at each site;

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 4, 2026