Colorectal neoplasms Colorectal cancer Colonic polyps Occult gastrointestinal bleeding Colorectal Neoplasms Capsule Endoscopy Artificial Intelligence Mass Screening Early Detection of Cancer Colonic Polyps Gastrointestinal Diseases Machine Learning
Conditions
Interventions
Participants undergo colon capsule endoscopy following standard bowel preparation. A 24 by 11 millimeter capsule containing an internal camera is swallowed to capture images of the colon throughout tr
Experimental Device
Sponsors
Fundamental Fund
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Individuals who underwent colorectal cancer screening with a fecal immunochemical test and received a positive result 2. Able to swallow the capsule without known swallowing difficulties 3. Able to follow bowel preparation instructions 4. Able to provide written informed consent 5. Willing to comply with all study procedures including follow up assessments during the 12 month study period
Exclusion criteria
Exclusion criteria: 1. Known or suspected gastrointestinal obstruction, strictures, or motility disorders that may prevent capsule passage 2. History of abdominal surgery that may interfere with capsule transit 3. Known inflammatory bowel disease 4. Pregnancy or suspicion of pregnancy 5. Known allergy or contraindication to bowel preparation agents 6. Presence of any severe medical or psychiatric condition that may interfere with study participation or safety 7. Inability to understand study information or provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic outcomes Day of capsule endoscopy Sensitivity, specificity, positive predictive value, negative predictive value, and receiver operating characteristic curve and area under the curve | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of colorectal lesions by AI-assisted colon capsule endoscopy Day of capsule endoscopy Proportion of participants with colorectal lesions detected by AI-assisted CCE | — |
Countries
Thailand
Contacts
Public ContactPradermchai Kongkam
chulalongkorn university
Outcome results
None listed