Gastrointestinal disorders
Conditions
Interventions
Gold Standard:Diagnosis of comparative device
Index test:Diagnosis of test device
Sponsors
Shenzhen Bao'an People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Ages 8 to 70 years old and gender is not limited 2. Those with or without upper gastrointestinal symptoms for whom gastroscopy is proposed 3. Those who are able to understand the purpose of the trial, who voluntarily participate and sign an informed consent form, and who are willing to comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1. Gastrointestinal obstruction, digestive tract malformation, digestive tract perforation, stenosis or fistula, etc. confirmed by examination 2. Those in the acute stage of corrosive esophageal injury 3. All kinds of acute enteritis, severe iron deficiency disease and radiation enteritis, such as active stage of bacillary dysentery, acute stage of ulcerative colitis, diverticulitis, etc 4. Those who have a history of gastrolithiasis and those who have undergone gastrointestinal surgery in the last three months 5. Those with severe dysphagia, or those who cannot insert the gastroscope due to acute severe pharyngeal disorders, etc 6. Those who have pacemakers (except for new MRI-compatible products), defibrillators, electronic cochlear implants, magnetic metal drug infusion pumps, neurostimulators, magnetic metal foreign bodies, and other electronic instruments implanted in the body that are susceptible to magnetic field interference 7. Those who are allergic to anesthesia drugs, or gastric preparation drugs such as defoaming agent simethicone emulsion, streptozotocin granules, pure sodium bicarbonate powder, or polymer materials 8. Pregnant and lactating women 9. Patients with severe heart disease such as severe arrhythmia, active stage of myocardial infarction, severe heart failure, congestive heart failure 10. Patients who cannot lie down due to severe lung diseases such as asthma, respiratory failure, etc 11. Patients with severe renal insufficiency 12. Those who have incurable bleeding factors or are receiving anticoagulation therapy 13. Those who have participated in other interventional clinical trials within one month and have not met the primary endpoints 14. Those with other contraindications to gastroscopy 15. Other conditions that in the judgment of the investigator are not suitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic concordance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Image analysis software function evaluations;Subject discomfort level;Subject discomfort level;negative gastric diagnostic accordance rate;Evaluation of magnet controlled capsule endoscope system;Subjects' gastric preparation quality;Gastroscopy results;Proportion of good quality images;Inspection time; | — |
Countries
China
Contacts
Public ContactFu Ya
Shenzhen Bao'an People's Hospital
Outcome results
None listed