Diseases of upper gastrointestinal tract
Conditions
Interventions
Study group:To perform magnetically controlled capsule endoscopy (InsightEyes EGD System)
Control group:To perform magnetically controlled capsule endoscopy (ANKON Controllable Stomach Capsule System)
Sponsors
the First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects, having clear understanding of the potential benefits and risks of this study, must be capable and voluntarily willing to enter the study and give written informed consent. 2. Male or female subjects aged 18 to 75 years old, inclusive with 18 and 75. 3. Subjects require magnetically controlled capsule endoscopy for various circumstances including but not limited to following: a) Subjects require health checkup of the upper gastrointestinal tract (including esophagus, stomach, duodenum); b) Subjects, who present with symptoms such as abdominal distension, epigastric pain, acid regurgitation, belching, require esophagogastroduodenoscopy; c) Subjects being examined for drug-related gastric mucosal damage, such as anticoagulant drugs or nonsteroidal anti-inflammatory drugs; d) Follow-ups for certain stomach conditions, such as esophageal and fundic varices, chronic atrophic gastritis, post-clinical treatment of peptic ulcers or post-endoscopic resection of esophageal or gastric polyps; e) Follow-ups after partial gastrectomy or endoscopic microinvasive operations; f) Subjects exhibiting abnormalities suggested on other imaging tests, such as abdominal CT scan or barium fluoroscopy; g) High-risk Subjects over forty years old with family histories of esophageal or gastric malignancy require annual esophagogastroduodenoscopy; h) Subjects go through screenings of gastric cancer. 4. Eligible subjects must have good communication with investigators and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female subjects; 2. Subjects are ineligible for or decline any abdominal surgeries, including endoscopic surgeries; 3. Subjects with metallic implants, such as removable dentures, metal stents, artificial joints, bone plates, and pins; 4. Subjects with implanted electronic devices, such as pacemakers, cochlear implants, magnetic drug infusion pumps, neurostimulators, etc., as well as magnetic metals or foreign bodies; 5. Subjects with previously known or suspected gastrointestinal obstruction, stenosis, or fistula; 6. Subjects suffer from defecation disorders caused by bowel obstruction or organic digestive system diseases; 7. Subjects with anatomical changes caused by gastrointestinal or abdominal surgeries; 8. patients with severe cardiac and pulmonary diseases, acute esophageal or gastrointestinal perforations, acute erosive esophagitis, and acute severe pharyngeal diseases; 9. Subjects in conditions of acute enteritis, severe ischemia disease, and radiation colitis, such as acute bacillary dysentery, acute ulcerative colitis, particularly amid its fulminant stage; 10. Subjects are allergic to medicines or high molecular materials; 11. Subjects has dysphagia or fail to swallow capsule endoscopy simulators; 12. Subjects with comprehensive anticoagulation or severe coagulation disorders; 13. Subjects with obvious gastrointestinal bleeding; 14. Subjects with waist circumference exceeding 120 cm (potentially affecting the maneuverability); 15. Subjects with severe epilepsy or mental illness; 16. Subjects with alcohol dependence or drug addiction; 17. Subjects with prolonged use of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs); 18. Subjects are enrolled in another clinical trial within one month prior to the time of inclusion; 19. Subjects who are excluded by investigators for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete observation of upper gastrointestinal tract; | — |
Secondary
| Measure | Time frame |
|---|---|
| the Rate of Optimal Imaging ;Rate of Observation of Individual Sections of Upper Gastrointestinal Tract;Duration of Examination ;Subjects' Endurance;Stability;Operators' Satisfaction;Rate of defect;Rate of AE;Vital Signs; | — |
Countries
China
Contacts
Public ContactHong Xu
the First Hospital of Jilin University
Outcome results
None listed