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A prospective single-center validation study to evaluate the diagnostic accuracy of IDEA in esophagogastroduodenoscopy for Helicobacter pylori infection

A prospective single-center validation study to evaluate the diagnostic accuracy of IDEA in esophagogastroduodenoscopy for Helicobacter pylori infection

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060178
Enrollment
Unknown
Registered
2022-05-21
Start date
2022-05-30
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Helicobacter pylori infection

Interventions

Index test:IDEA in diagnosing Helicobacter pylori infection status by white-light endoscopy

Sponsors

Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. More food, foreign body and bleeding in the stomach obviously affect the observation of gastric mucosa; 2. Large lesions such as advanced cancer and giant ulcer affected gastric mucosa; 3. Incomplete gastric cavity after upper digestive tract operation; 4. Recently taking antibiotics, PPI, bismuth drugs; 5. Data were missing, including missing endoscope pictures and missing 14C-UBT test results.

Design outcomes

Primary

MeasureTime frame
The accuracy of diagnosing Helicobacter pylori infection;The specificity of diagnosing Helicobacter pylori infection;

Secondary

MeasureTime frame
The sensitivity of diagnosing Helicobacter pylori infection;The positive predictive value of diagnosing Helicobacter pylori infection;The negaitive predictive value of diagnosing Helicobacter pylori infection;

Countries

China

Contacts

Public ContactWang Shi

Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

wangshi@zjcc.org.cn+86 13588403693

Outcome results

None listed

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