Skip to content

Objiective to evaluate a prospective, self-controlled, multicenter clinical study of OMOM colon capsule endoscopy system CC100 versus electronic colonoscopy for the detection of colon disease

Objiective to evaluate a prospective, self-controlled, multicenter clinical study of OMOM colon capsule endoscopy system CC100 versus electronic colonoscopy for the detection of colon disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053674
Enrollment
Unknown
Registered
2021-11-27
Start date
2022-03-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Colon diseases

Interventions

Gold Standard:electronic colonoscopy
endoscopy

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily participate in the trial and sign the informed consent; 2. Aged 18-70 years, gender is not limited; 3. In line with the indications for colon examination, any one of the following can be included in the group: healthy people; high-risk groups of lower gastrointestinal tumors, including family history, irregular life, poor eating habits, alcoholism, etc.; suspicious lower digestive system Symptoms, such as abdominal distension, abdominal pain, diarrhea, blood in the stool, etc.; Digestive system diseases that require regular review, including bowel polypectomy, ulcerative colitis, colonic diverticulum, etc.; Other definite or suspected colon diseases require colon examination; 4. Able to communicate well with investigators and comply with trial requirements.

Exclusion criteria

Exclusion criteria: 1. Acute peritonitis, intestinal perforation, extensive intra-abdominal adhesion, etc.; 2. Known or suspected gastrointestinal obstruction, stenosis and fistula; 3. Those who have undergone intestinal surgery in the past; 4. Those with severe perianal rectal disease who cannot insert the endoscope; 5. Defecation disorder; 6. Those with pacemakers or other electronic devices implanted; 7. Those who have a history of severe allergies in the past and those who are allergic to anesthetic drugs; 8. People with dysphagia; 9. Those with a history of abdominal surgery; 10. Pregnant women; 11. Those whose physical conditions cannot tolerate the bowel preparation program used in the study; 12. Others considered by the researchers to be unsuitable for colon capsule and electronic colonoscopy.

Design outcomes

Primary

MeasureTime frame
The consistency of lesions detected;

Secondary

MeasureTime frame
The completion rate of total colon examination;The transit time of stomach, small intestine and colon ,and total working time of colon capsule endoscopy;Colon cleanliness score;The lesions examination results of esophageal, gastric and small intestinal;

Countries

China

Contacts

Public ContactYang Shiming

Department of Gastroenterology, Second Affiliated Hospital of Army Medical University

13228686589@163.com+86 13228686589

Outcome results

None listed

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