Gastric Symptoms, Indicated for Upper GI Endoscopy
Conditions
Brief summary
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
Interventions
DEVICEMCE
MCE first, followed by standard gastroscopy
DEVICEStandard gastroscopy
Sponsors
Second Military Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with gastric symptoms and indicated for Upper GI endoscopy * Age of 18 years to 70 years
Exclusion criteria
* Patients with impaired bowel movement from ileus or organic digestive diseases * Patients with known large and obstructing tumors of the upper GI tract * Patients after upper GI surgery or abdominal surgery altering GI anatomy * Patients under full anticoagulation * Patient in poor general condition * Patients using equipment that may be affected by radio transmission * Patients using equipment that may be affected by magnetic field * Pregnancy or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| Examination times of capsule and standard gastroscopy | 1 hour |
| Patient acceptance of capsule gastroscopy and standard gastroscopy | 3 days |
| Adverse events of both procedures | 2 weeks |
Countries
China
Outcome results
None listed