Gastric diseases (including chronic gastritis, gastric ulcers, gastric polyps, gastric tumors, etc.)
Conditions
Interventions
Gold Standard:Comprehensive diagnosis of painless electronic gastroscopy
Note: The final decision is based on the findings of painless electronic gastroscopy and the diagnosis of clinical endoscopy.If
If there is no definite abnormality under endoscopy or only simple chronic superficial gastritis, it is judged as negative (the target disease does not exist).
Index test:Accuracy (Overall Agreement) is the diagnostic consistency rate, ( true positive + true negative) / total cases.
Sensitivity / Positive Percent Agreement (PPA) The proportion of Positive te
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Meet the indications for gastric examination, one of the following groups can be included in the group: (1) Health examiners; (2) High-risk groups of upper gastrointestinal cancer, including family history, irregular life, poor eating habits, alcoholism, etc.; (3) Presence of suspicious symptoms of the digestive system, such as abdominal distension, abdominal pain, nausea, epigastric heartburn, etc.; (4) Follow-up of gastric ulcer, gastric polyp, gastric fundus varices, erosive and atrophic gastritis; (5) Preliminary screening of gastric cancer (superficial tumors, etc.); (6) Evaluation and monitoring of drug-related gastrointestinal mucosal injury; 3. Be able to communicate well with researchers and comply with test requirements; 4. Participate in the clinical trial voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant women; 2. No surgical conditions or refusal to accept any abdominal surgery, because once the capsule remains, it will not be removed by surgery; 3. Patients with pacemakers, electronic cochlea, drug perfusion pump, nerve stimulator, and other electronic devices; 4. Gastrointestinal obstruction, stenosis, and fistula are known or suspected; 5. Allergy to polymer materials, dysphagia, or capsule simulator swallowing failure; 6. All patients after gastrectomy or intestinal resection, because the capsule may be retained in the stomach or intestine, affecting the outcome of the examination; 7. Patients who participated in other clinical trials within one month; 8. Other patients deemed unfit to participate in this clinical trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic concordance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive concordance rates;Negative concordance rates;Examination completion rate;Gastric anatomical coverage;Mean length of stay;Mean inspection time;72 hour discharge rate;Lesions detection rate of test apparatus;Satisfaction evaluation; | — |
Countries
China
Contacts
Public ContactBeiping Zhang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed