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A prospective, single-arm objective performance criteria designed, single-center trial for evaluating the performance of EndoAngel in detecting focal lesions and diagnosing neoplasms of the stomach in white light endoscopy

A prospective, single-arm objective performance criteria designed, single-center trial for evaluating the performance of EndoAngel in detecting focal lesions and diagnosing neoplasms of the stomach in white light endoscopy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045963
Enrollment
Unknown
Registered
2021-04-30
Start date
2021-05-06
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Gastric neoplasms

Interventions

Gold Standard:Pathologic diagnosis
Index test:EndoAngel&#32
in&#32
diagnosing&#32
gastric&#32
neoplasms&#32
by&#32
white-light&#32
endoscopy

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Over(above) 18 years old; 2.Patients with sedated gastroscopy; 3.Patients who can read, understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with emergency bleeding; 2.Patients with large amounts of food residues; 3.Patients with a history of previous gastrectomy or diagnosed as remnant stomach.

Design outcomes

Primary

MeasureTime frame
The sensitivity of detecting focal lesions;The sensitivity of diagnosing gastric neoplasms;—

Secondary

MeasureTime frame
The accuracy of diagnosing gastric neoplasms;The specificity of diagnosing gastric neoplasms;The positive predictive value of diagnosing gastric neoplasms;The negative predictive value of diagnosing gastric neoplasms;The false-positive box mean number of detecting gastric abnormities;—

Countries

China

Contacts

Public ContactYu Honggang

Department of Gastroenterology, Renmin Hospital, Wuhan University

yuhonggang@whu.edu.cn+86 13871281899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026