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Prospective Diagnostic Study on Rapid Assessment of Gastric Helicobacter Pylori Infection and Drug Resistance Based on ROSE Technology

Prospective Diagnostic Study on Rapid Assessment of Gastric Helicobacter Pylori Infection and Drug Resistance Based on ROSE Technology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125137
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Gastritis caused by Helicobacter pylori

Interventions

Gold Standard:Take the results of microbial culture as the gold standard Reference gold standard test: Microbial culture combined with drug sensitivity test: As the gold standard for determining HP in
Index test:The diagnostic tests to be evaluated in this study are as follows, covering the core technologies to be validated, associated analysis indicators, and reference control methods, all of whic

Sponsors

The 8th Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 Aged 18-75 years old 2 Those undergoing gastroscopy for the first time, or those re-examining after stopping medication (antibiotics, bismuth for 4 weeks; PPI for 2 weeks)

Exclusion criteria

Exclusion criteria: 1 History of gastric surgery 2 Presence of coagulation dysfunction 3 Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
M-ROSE Observation Indicators;Accuracy;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactZhang Lin

The 8th Medical Center of PLA General Hospital

stepinghuns2@163.com+86 138 1176 5253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026