Objective to evaluate the efficacy and safety of navigation magnetic capsule endoscopy system in gastric and small bowel examination

Prospective, multicenter, self-control efficacy and safety of navigation magnetic capsule endoscopy system for gastric and small bowel examination

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040507

Enrollment

Unknown

Registered

2020-12-01

Start date

2020-12-01

Completion date

Unknown

Last updated

2021-03-08

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

Conditions

Gastrointestinal diseases

Interventions

experience group:Magnetic capsule endoscopy

Control group:Electronic gastroscopy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old; 2. The subjects voluntarily participate in the trial and sign the informed consent form; 3. Healthy volunteers; or suspected upper gastrointestinal lesions, requiring electronic gastroscopy; or unexplained gastrointestinal bleeding, abdominal pain, diarrhea, requiring enteroscopy or small bowel capsule endoscopy; 4. Be able to communicate well with researchers and comply with the test requirements.

Exclusion criteria

Exclusion criteria: 1. Dysphagia; 2. Acute severe throat disease and corrosive esophagitis; 3. Perforation of esophagus, stomach and duodenum; 4. Confirmed or suspected digestive tract obstruction, stenosis and fistula; 5. Active gastrointestinal bleeding; 6. Severe renal insufficiency; 7. Abdominal surgery within half a year; 8. Implantation of cochlear, magnetic metal drug infusion pump, nerve stimulator and other electrical devices Results: the patients were divided into three groups: sub device and magnetic metal foreign body; 9. Pregnant and lactating women; 10. Mental disorders or uncooperative persons; 11. Patients with BMI > 35kg / m2; 12. Patients without operation conditions or refusing to accept any abdominal surgery; 13. Other patients who were considered unsuitable for magnetic controlled capsules and painless electronic gastroscopy by the researchers.

Design outcomes

Primary

Measure	Time frame
Complete rate of intragastric examination;	—

Secondary

Measure	Time frame
Consistency of detection of intragastric diseases;Complete rate of whole small bowel examination (CR);Magnetic control capsule stomach automatic control examination time;Transit time of small intestine;Number of images of small intestine examination;	—

Countries

China

Contacts

Public ContactXiaoyan Zhao

The Second Affiliated Hospital of Army Medical University

Zhaoxiaoyan2018@126.com+86 13808395965

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026