Skip to content

A clinical trial of capsule endoscopic system

A clinical trial of capsule endoscopic system

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099664
Enrollment
Unknown
Registered
2025-03-27
Start date
2024-07-03
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

gastric disease

Interventions

Gold Standard:Electronic upper gastrointestinal endoscope (Olympus,GIF-290)
Index test:Magnetically controlled capsule endoscope (Shenzhen Silicon Intelligent Control Technology Co., LTD, CE-1)

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-70 years old; 2.Health people or population at risk of gastric cancer, including helicobacter pylori infection,and people with a history of stomach disease (gastric polyps, gastric submucosal masses, gastric precancerous lesions and early gastric cancer); 3.Voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Those who have no surgical conditions or refuse to undergo any abdominal surgery; 3. Patients with electronic devices such as cardiac pacemakers, electronic cochlear implants, drug infusion pumps, nerve stimulators or magnetic metal objects, except magnetic resonance image-compatible products; 4. Patients with acute gastrointestinal diseases: judged or suspected to have gastrointestinal obstruction, stenosis, fistula and diverticulum; obvious gastrointestinal bleeding, acute stage of gastrointestinal perforation; acute enteritis, such as bacillary dysentery and acute ulcerative colitis; 5. Patients in poor condition, such as renal insufficiency and congestive heart failure; 6. Patients with mental disorder or psychological disorder that can not cooperate with the examination; 7. Patients who are allergic to polymer materials, patients with dysphagia or esophageal atrophy, patients failed esophageal atrophy or capsule simulant swallowing; 8.Patients after gastric and intestinal resection, patients with intractable constipation or gastrointestinal motility disorder; 9. Other patients that the investigator considers inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Prevalence of different types of gastric focal lesions by magnetically controlled capsule endoscopy;Performance of magnetically controlled capsule endoscopy in detecting gastric focal lesions;Follow-up of population at risk of gastric cancer;Safety evaluation;Application evaluation;

Countries

China

Contacts

Public ContactXinying Wang

Zhujiang Hospital of Southern Medical University

xinyingwang06@163.com+86 137 2675 4880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026