Diseases of the small intestine
Conditions
Interventions
First group:Test the device first, and then check the device against
Second group:Test the device first, and then check the device against
Sponsors
Bao'an Distric Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
8 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 8~70 (inclusive) years old, gender is not limited; (4) The subject voluntarily participates in the trial and signs the informed consent form; 3) Eligible for inclusion in any of the indications for capsule endoscopic system examination: 3.1 Causes of gastrointestinal bleeding, no positive findings by upper and lower gastrointestinal microscopy; 3.2 cT, NERI, ultrasound and other examinations suggest abnormal imaging of the small intestine; 3.3 Various inflammatory bowel diseases, but excluding intestinal obstruction; 3.4 Unexplained abdominal pain, diarrhea; 3.5 Small bowel tumors (benign, malignant and carcinoid, etc.); 3.6 Review of multiple polyps and Crohn's disease; 3.7 Unexplained iron deficiency anemia. 3.8 Clinician-evaluated, suitable. 4) Be able to communicate well with the investigator and comply with the test requirements
Exclusion criteria
Exclusion criteria: Subjects participating in this study must not meet any of the following criteria: 1) Examination confirmed gastrointestinal obstruction, digestive tract malformations, digestive tract perforation, stenosis or fistula, etc.; 2) Those who implant electronic instruments in the body, such as pacemakers; 3) Researchers judged to have various acute enteritis, severe iron deficiency diseases and radiation enteritis, such as bacterial dysentery active phase, acute phase of ulcerative colitis, diverticulitis, etc.; 4) Those with a history of gastrolithiasis and those who have undergone digestive tract surgery in the past three months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic consisrency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of excellent image quality;Gut cleanliness;Invivo residence time of capsule endoscopy;Capsule endoscopy for residence time in various organs;Capsule working hours;Functional assessment of the image analysis software;The number and quality of esophageal images captured by capsule endoscopy in the investigator trial group; | — |
Countries
China
Contacts
Public ContactCheng Honghui
Bao'an Distric Hospital of Traditional Chinese Medicine
Outcome results
None listed