Small Bowel Disease
Conditions
Interventions
Single Group:Device: AKES-31SW and AKES-11SW First swallow the trial device(AKES-31SW) for examination, and then swallow the comparator device(AKES-11SW) for examination at an interval of 2h. Device:
Sponsors
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Both male and female, age 18; 2. Those who needs undergo capsule endoscopy; 3. Agree to participate in the clinical trial and sign an informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who have participated in other clinical trials or are participating in other clinical trials within three months; 2. Subjects who have no surgical conditions or refuse to accept any abdominal surgery (which cannot be removed by surgery once the capsule is retained); 3. Subjects who have a cardiac pacemaker installed in their body, except where pacemakers are new MRI compatible products; 4. Subjects who have cochlear implants, magnetic metal drug perfusion pumps, nerve stimulators, and magnetic metal foreign bodies; 5. Subjects plan magnetic resonance (MRI) examiners before capsule endoscopy; 6. Subjects known or suspected gastrointestinal obstruction, stenosis, diverticulum, fistulae, or active major bleeding; 7. Subjects previous history of abdominal surgery affecting the normal digestive tract; 8. Pregnant women; 9. Subjects with mental illness; 10. Subjects severe asthma, swallowing or gastric paralysis; 11. Subjects in poor general conditions,couldn't to tolerate capsule endoscopy; 12. There are any other influencing factors that are considered unsuitable for participants to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of the small bowel examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastric transit time;Small-bowel transit time;Exhaust time;Detection rate of small bowel lesions;Image quality;Swallow comfort; | — |
Countries
China
Contacts
Public ContactXiaoHua Hou
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed