Examination of stomach and / or small intestine diseases
Conditions
Interventions
AKES-31SW group:AKES-31SW capsule endoscopy check up
GIVEN group:GIVEN capsule endoscopy check up
AKEM-11SW group:AKEM-11SW capsule endoscopy check up
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The first part (accepting AKES-31SW examination) 1) Male or female, aged >= 18 years; 2) The patients who are going to have small intestine capsule endoscopy, whether they have digestive system discomfort or not; 3) They agreed to participate in the clinical trial and signed the informed consent. The second part (accepting the AKEM-31SW examination): 1) Male or female, aged >= 18 years; 2) The patients who completed the magnetic capsule gastroscopy, no matter whether they had digestive system discomfort or not; 3) They agreed to participate in the clinical trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who have participated in other clinical trials or are participating in other clinical trials within three months; 2) Those who have no surgical conditions or refuse to accept any abdominal surgery (once the capsule is retained, it will not be removed by surgery); 3) Cardiac pacemaker is installed in the body, except that the pacemaker is a new MRI compatible product; 4) Cochlear implant, magnetic metal drug infusion pump, nerve stimulator and other electronic devices and magnetic metal foreign bodies were implanted in vivo; 5) MRI examination was planned before capsule endoscopy was discharged; 6) Gastrointestinal obstruction, stenosis, diverticulum, fistula or active massive hemorrhage are known or suspected; 7) Previous abdominal operation history affecting normal structure of digestive tract; 8) Pregnant women; 9) Patients with mental illness; 10) Severe asthma, dysphagia, gastroparesis and other emptying disorders; 11) The general condition was poor, and could not tolerate MCE examination; 12) The researchers believe that there are any other factors that are not suitable for subjects to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The completeness of GI tract examination;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comfort of swallowing capsule;Manipulation performance of capsule endoscopy;Check the relevant time indicators;Image quality;Disease detection rate;Lighting flash time range;Overall comfort of the subjects; | — |
Countries
China
Contacts
Public ContactXiaohua Hou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed