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

Research on Endoscopic Recognition of Helicobacter pylori Infection Auxiliary Diagnosis Model Based on Deep Learning and Image Enhancement

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400088612

Enrollment

Unknown

Registered

2024-08-22

Start date

2024-09-19

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Helicobacter pylori infection

Interventions

Gold Standard:Urea Breath Test

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

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. Perform 14C-UBT testing on the day of gastroscopy examination.

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

Measure	Time frame
The accuracy of diagnosing Helicobacter pylori infection;The sensitivity of diagnosing Helicobacter pylori infection;The specificity of diagnosing Helicobacter pylori infection;	—

Secondary

Measure	Time frame
The positive predictive value of diagnosing Helicobacter pylori infection;The negaitive predictive value of diagnosing Helicobacter pylori infection;	—

Countries

China

Contacts

Public ContactLi Yandong

Zhejiang Cancer Hospital

liyd@zjcc.org.cn+86 150 5815 5120

Outcome results

None listed

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