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The feasibility and safety of a novel single used upper gastrointestinal endoscopy and image processing system: a prospective, randomised, controlled, open-label, multicenter, non-inferiority trial

The feasibility and safety of a novel single used upper gastrointestinal endoscopy and image processing system: a prospective, randomised, controlled, open-label, multicenter, non-inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029945
Enrollment
Unknown
Registered
2020-02-17
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

upper gastrointestinal disease

Interventions

A novel single used upper gastrointestinal endoscopy:A novel upper gastrointestinal endoscopy examination
GIF-Q260J:GIF-Q260J upper gastrointestinal endoscopy examination

Sponsors

The Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 and 75 years; 2. Scheduled for upper gastrointestinal endoscopy; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: There is one of the followings which should be excluded. 1. Severe cardiopulmonary disease; 2. Upper gastrointestinal perforation; 3. Shock; 4. Severe laryngeal disease; 5. Acute erosive esophagitis; 6. Thoracoabdominal aortic aneurysm; 7. Stroke; 8. History of mental illness and cognitive impairment; 9. Allergic anesthetic drug; 10. Coagulation dysfunction; 11. Hb < 50g/L; 12. Pregnancy or lactation; 13. Participating in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Image quality;—

Secondary

MeasureTime frame
Device quality;—

Countries

China

Contacts

Public ContactLisheng Wang

The Second Clinical Medicine College (Shenzhen People's Hospital) of Jinan University

wanglsszrmyy@163.com+86 13714725662

Outcome results

None listed

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