Skip to content

A prospective, multicenter, self-controlled clinical trial to evaluate the efficacy and safety of magnetron capsule endoscopic system in the diagnosis of upper digestive tract diseases

A prospective, multicenter, self-controlled clinical trial to evaluate the efficacy and safety of magnetron capsule endoscopic system in the diagnosis of upper digestive tract diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063630
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-09-13
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive tract disease

Interventions

Gold Standard:Take the results of electronic gastroscopy as the gold standard
Index test:Magnetron capsule endoscope system

Sponsors

Pekin University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 with no restriction on gender; 2. Plan to undergo upper gastrointestinal examination 3. Can understand the purpose of the test, voluntarily participate in and sign the informed consent, and are willing to comply with the requirements of the test.

Exclusion criteria

Exclusion criteria: 1. Implanters of electronic devices that are susceptible to magnetic field interference, such as cardiac pacemakers (except new MRI compatible products), defibrillators, cochlear implants, magnetic metal drug infusion pumps, nerve stimulators, and magnetic metal foreign bodies; 2. Those who are allergic to anesthetic drugs or polymer materials; 3. Pregnant women; 4. Patients with severe heart disease such as severe arrhythmia, active myocardial infarction, severe heart failure, congestive heart failure, etc.; 5. Patients with severe lung diseases such as asthma and respiratory failure cannot lie down, etc.; 6. Severe renal insufficiency; 7. Acute perforation of esophagus, stomach and duodenum; 8. Those with acute severe throat disease who cannot insert gastroscope; 9. Acute stage of erosive esophageal injury; 10. People with dysphagia; 11. Those who have incurable bleeding factors or are receiving anticoagulation therapy; 12. Those who participated in clinical trials of other devices or drugs within 1 month but did not reach the primary endpoint; 13. There are other contraindications for gastroscopy; 14. Other circumstances judged by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Evaluation of cleanliness of upper digestive tract;Evaluation of mucosal display degree of upper digestive tract;Tolerance assessment;

Countries

China

Contacts

Public ContactLong Rong

Pekin University First Hospital

drronglong@foxmail.com+86 10 8357 2437

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026