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Clinical study on the application of a new type of ultrafine magnetic-assisted capsule endoscope in upper gastrointestinal tract examination

Clinical study on the application of a new type of ultrafine magnetic-assisted capsule endoscope in upper gastrointestinal tract examination

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060597
Enrollment
Unknown
Registered
2022-06-05
Start date
2022-05-30
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Diseases of upper gastrointestinal tract

Interventions

Group one:Stringed magnetic-controlled capsule endoscopy

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The subjects themselves or their legal representatives participate voluntarily under their free will and sign the informed consent of the patients; 2. Aged between 18 and 75 (on the date of signing the informed consent), with no restriction on gender; 3. Healthy volunteers or patients with symptoms suspected to be caused by upper gastrointestinal diseases (such as abdominal pain, abdominal distension, nausea, vomiting, belching, acid reflux, heartburn, melena, weight loss, etc.); 4. Able to describe correctly and willing to comply with requirements of the clinical trials.

Exclusion criteria

Exclusion criteria: 1. Implanted pacemakers or other electronic medical devices susceptible to magnetic field interference; 2. Allergic to narcotic drugs or polymer materials; 3. Pregnancy; 4. Congestive heart failure, renal insufficiency or other serious cardiopulmonary diseases, in poor general condition, and under therapeutic anticoagulation; 5. Patients with other contraindications for gastroscopy; 6. The investigator considers that there are any factors that are inappropriate for inclusion or that affect the participant's participation.

Design outcomes

Secondary

MeasureTime frame
the maneuverability of MACE;Upper gastrointestinal mucosal cleanliness and visualization;

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactMeng Ke

The First Medical Center of Chinese PLA General Hospital

mengke301@126.com+86 15901210390

Outcome results

None listed

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