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Diagnostic clinical study of a novel noninvasive detection of helicobacter pylori in human exhalation

Diagnostic clinical study of quantum cascade lasers (QCL) detection of C13 for helicobacter pylori in human exhalation

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039837
Enrollment
Unknown
Registered
2020-11-12
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Gastritis, Upper gastrointestinal ulcer

Interventions

Gold Standard:Results of carbon 13- urea breath test
detection&#32
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reliabilty.

Sponsors

Sichuan Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects aged 18-70 years, regardless of gender, who plan to undergo C13-UBT test.

Exclusion criteria

Exclusion criteria: 1. Myocardial infarction, stroke and shock in the last 3 months; 2. Patients with severe cardiac insufficiency, severe arrhythmia, unstable angina, severe hypertension and hypertensive crisis (systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg) in the last 4 weeks, or patients with thoracic and abdominal aortic aneurysm; 3. Patients with pneumothorax and pneumothorax within 1 month after pneumothorax healing, patients with severe pulmonary bullae, severe hypoxemia and severe respiratory failure; 4. Hemoptysis in recent 4 weeks;Seizures require medical treatment; On the day of pulmonary function examination, after endoscopy and biopsy; 5. Severe hyperthyroidism; 6. Vulnerable to infection due to low immunity; 7. Patients with weak or myasthenia gravis: 8. Unable to cooperate: such as severe cough, hemiplegia, facial palsy, cerebral palsy, as well as mentally disabled patients, deaf patients; 9. Allergic history to PE materials; 10. Pregnant or lactating women; 11. The investigator did not consider it appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
C13 content;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactLi Qiang

Sichuan Cancer Hospital and Institute

liqiang1907@vip.sina.com+86 18908178887

Outcome results

None listed

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