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A prospective, single-arm objective performance criteria designed, multi-center trial for evaluating the performance of ENDOANGEL in diagnosing gastric neoplasms in white light endoscopy

A prospective, single-arm objective performance criteria designed, multi-center trial for evaluating the performance of ENDOANGEL in diagnosing gastric neoplasms in white light endoscopy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042180
Enrollment
Unknown
Registered
2021-01-15
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Gastric neoplasms

Interventions

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 or above; 2) Further gastroscopy is needed to identify the characteristics of digestive tract diseases; 3) Sedated gastroscopy; 4) Able to read, understand and sign the informed consent; 5) The investigator believes that the subject is able to understand the procedures of the clinical study and is willing and able to complete all study procedures and follow-up visits and to cooperate with the study procedures.

Exclusion criteria

Exclusion criteria: 1) Has participated in other clinical trials, signed informed consent, and is in the follow-up period of other clinical trials; 2) Has participated in a drug clinical trial and is in the washout period of the experimental or control group; 3) Has drug abuse, alcohol abuse, or mental disorder in the last 5 years; 4) Pregnant or lactating women; 5) Subjects who have had previous gastric surgery or have been diagnosed with residual stomach; 6) Subjects with biopsy contraindications; 7) Subjects with known active upper gastrointestinal bleeding or under emergency gastroscopy; 8) Subjects who, in the opinion of the investigator, are not suitable for sedated gastroscopy; 9) Subject who were not eligible for sedated gastroscopy as assessed by the anesthesiologist; 10) Subjects with medical conditions or other special situations that make the subjects unsuitable for the clinical trial in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
accuracy;sensitivity;specificity;

Secondary

MeasureTime frame
PPV;NPV;

Countries

China

Contacts

Public ContactYu Honggang

Department of Gastroenterology, Renmin Hospital, Wuhan University

yuhonggang1968@163.com+86 13871281899

Outcome results

None listed

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