Clinical Evaluation of Diagnostic Support Software for Colonoscopy

Prospective Evaluation of a Computer-aided diagnosis for Narrow-Band Imaging of Colorectal Lesions - NBI-CAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044362

Enrollment

350

Registered

2021-12-25

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Colorectal neoplasms

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who do not have any previous information regarding colorectal polyp and will undergo colonoscopy at the Digestive Disease Center, Showa University Northern Yokohama Hospital during the period from the approval by the IRB to December 31, 2021. 2) Patients who are 40 years old or older at the time of examination

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To demonstrate that the lower limit of the confidence interval for the sensitivity of NBI-CAD to diminutive colorectal neoplasms exceeds 90%.	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactMasashi Misawa

Showa University Northern Yokohama Hospital Digestive Disease Center

mmisawa@med.showa-u.ac.jp045-949-7000

Outcome results