Gastric diseases
Conditions
Interventions
Experimental group:Capsule endoscopy
Control group:Electronic gastroscopy examination
Sponsors
Wuxi Fusheng Intelligent Medical Technology Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 70 years old (inclusive). Gender: No restrictions. 2. Any one of the following conditions for gastroscopy can be selected to be included in the study: (1) Healthy individuals undergoing physical examination; (2) High-risk groups for gastric cancer such as Helicobacter pylori carriers, those with a family history of gastric cancer, those with irregular eating habits, or a history of excessive alcohol consumption, etc.; (3) People with upper gastrointestinal symptoms, including upper abdominal discomfort, bloating, pain, heartburn and acid reflux, belching, hiccups, unexplained loss of appetite, weight loss, black stool, anemia, etc.; (4) Individuals with gastric diseases who need regular follow-up, including atrophic gastritis, gastric polyps, gastric ulcers, etc.; (5) Other individuals with clear or suspected gastric diseases who need to undergo gastroscopy; 3. Complete gastrointestinal physiological structure; 4. Voluntary participation in this clinical trial and signing the informed consent form for the subjects.
Exclusion criteria
Exclusion criteria: 1. Those with clear symptoms of dysphagia; 2. Those with acute severe throat disorders who cannot have the endoscope inserted, or those with acute-stage corrosive esophageal injury; 3. Those with various digestive tract malformations, digestive tract obstructions (including incomplete obstructions), digestive tract perforations, strictures or fistulas; 4. Patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis), patients with intestinal obstruction (including incomplete intestinal obstruction), diseases of gastrointestinal diverticula, narrow or narrowed intestinal fistulas, those who have undergone abdominal or pelvic surgery and have been judged by the study not suitable for inclusion; 5. Those whose digestive tract normal anatomical structure has been changed after esophageal and gastrointestinal surgeries (such as esophago-gastric anastomosis after surgery, gastrojejunostomy after surgery, etc.); 6. Patients with severe underlying diseases including cardiovascular diseases, respiratory system diseases, neurological diseases and other serious diseases who cannot tolerate the examination; 7. Those with limited mobility, physical weakness, mental abnormalities who cannot cooperate with the examination, or those with restricted behaviors who cannot cooperate with body position changes (such as obesity limitations, etc.); 8. Those with electronic devices in the body such as cardiac pacemakers, electronic cochlear implants, drug infusion pumps, nerve stimulators, etc.; 9. Those with severe bleeding tendency or abnormal coagulation function (APTT = 1.5 times the upper limit of the normal value) or those who have stopped taking anticoagulant or antiplatelet aggregation treatment drugs for less than 1 week; 10. Those with severe allergic constitution (allergic to two or more substances), allergic to the anesthetic drugs to be used in the trial or to medical polymer materials, suspected or diagnosed drug addicts; 11. Those who plan to undergo magnetic resonance imaging (MRI) or computed tomography (CT) examinations during the trial; 12. Pregnant or lactating women, those with pregnancy plans during the trial; 13. Those who participated in other interventional device clinical trials or completed the last medication of the drug clinical trial within 5 half-lives before this trial; 14. Those considered by the researchers to be other individuals not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of detecting focal lesions in the stomach; | — |
Secondary
| Measure | Time frame |
|---|---|
| The consistency rate, positive consistency rate, and negative consistency rate of detecting focal lesions in the stomach;;Gastric Cleanliness Assessment;Complete examination rate of typical structures in the stomach;Evaluation of gastric mucosal display degree;Comfort evaluation;Equipment performance evaluation;Sensitivity, specificity, and consistency of gastric disease detection; | — |
Countries
China
Contacts
Public ContactPeng Li
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed