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Clinical trial of capsule Endoscope system

Clinical trial of capsule Endoscope system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065028
Enrollment
Unknown
Registered
2022-10-26
Start date
2022-10-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Examination of small intestinal diseases (e.g. unexplained gastrointestinal bleeding, unexplained diarrhea, abdominal pain, etc.)

Interventions

intervention group:capsule endoscope system (C10000SI) examination
Control group:capsule endoscope system (JS-ME-I) examination

Sponsors

Beijing Friendship Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18-70 years of age (including 18 and 70 years of age), regardless of sex; 2. Clinical examination of the small intestine by capsule endoscopy (including, but not limited to, unexplained gastrointestinal bleeding, unexplained abdominal pain, unexplained diarrhea, and various inflammatory bowel diseases, except intestinal obstruction and intestinal stricture. ); 3. Complete physiological structure of the gastrointestinal tract; 4. The subject or his guardian was able to understand the purpose of the trial, show sufficient compliance with the research program, voluntarily participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with severe swallowing causes 2. patients with severe gastrointestinal motility disorders or severe constipation 3. Digestive tract malformation, stenosis, perforation or fistula; 4. Acute enteritis, severe ischemic diseases and radiation colitis, such as bacterial disease active phase, ulcerative colitis in acute phase, especially in fulminant type; 5. patients with pacemakers or other electronic instruments implanted in vivo; 6. those with known surgical anastomotic stenosis that may cause capsule retention; 7. patients with a history of gastrointestinal surgery; 8. patients with contraindications of surgery; 9. those who refuse abdominal surgery; 10. pregnant, lactating and mental patients; 11. those who are participating in clinical trials of other drugs / medical devices within or within three months 12. those who were unable to communicate their feelings accurately and could not communicate normally. 13. The researchers do not consider it appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Check the excellent and good rate of image quality;

Secondary

MeasureTime frame
Evaluation of use comfort of capsule endoscopy system;Evaluation of common functions of equipment;Evaluation of equipment service stability;Completion rate of total small bowel examination;

Countries

China

Contacts

Public ContactLi Peng

Beijing Friendship Hospital,Capital Medical University

lipeng@ccmu.edu.cn+86 13521136454

Outcome results

None listed

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