Clinical Evaluation of Diagnostic Support Software for Colonoscopy
Not Applicable
Completed
- Conditions
- Colorectal neoplasms
- Registration Number
- JPRN-UMIN000044362
- Lead Sponsor
- Showa University Northern Yokohama Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with polyposis, such as familial adenomatous polyposis. (2) Patients with inflammatory bowel disease (3) Patients who have expressed their refusal for the use of the information (4) Patients whose pathological diagnosis has been made previously, such as biopsy at a previous doctor's office (5) Patients who are taking antiplatelet agents or anticoagulants and for whom resection of the lesion is inappropriate.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that the lower limit of the confidence interval for the sensitivity of NBI-CAD to diminutive colorectal neoplasms exceeds 90%.
- Secondary Outcome Measures
Name Time Method (1) Specificity, NPV, PPV,accuracy of NBI-CAD for diminutive neoplasms. (2) Sensitivity, specificity, NPV, PPV, and accuracy of NBI-CAD for tumors larger than 5 mm, SSA/P, and hyperplastic polyps. (3) Sensitivity, specificity, NPV, PPV, accuracy of NBI-CAD for neoplasms when the diagnostic result of NBI-CAD is high confidence (probability >90%). (4)The sensitivity, specificity, PPV, NPV, and accuracy of NBI-CAD for neoplastic lesions at high confidence (probability > 90%). (5) Adenoma detection rate (6) Advanced adenoma / neoplasia detection rate (7) Time from cecal arrival to endoscope witdrawal (8) Presence and type of adverse events (9) Surveillance interval concordance rate