Colorectal Cancer and Precancerous Lesions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years, inclusive. 2. Scheduled for a screening, diagnostic, or surveillance colonoscopy. 3. Able to understand the study protocol and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known contraindications to colonoscopy or biopsy. 2. Personal history of colorectal cancer, inflammatory bowel disease (IBD), or previous colorectal surgery. 3. Known or suspected colorectal polyposis syndrome (e.g., Familial Adenomatous Polyposis - FAP). 4. Patients with active colorectal bleeding, bowel obstruction, or toxic megacolon. 5. Women who are pregnant, planning to become pregnant, or are breastfeeding. 6. Participation in another interventional clinical trial within the 30 days prior to enrollment. 7. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of lesion-level polyp detection,;Specificity of patient-level polyp detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity of patient-level polyp detection;polyp detection rate and polyps per colonoscopy;adenoma detection rate and adenomas per colonoscopy;Independent performance evaluation of the software;Boston Bowel Preparation Scale;Colonoscopy procedure duration;Software usability;Software stability; | — |
Countries
China
Contacts
The Second Affiliated Hospital, Zhejiang University School of Medicine