Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607083
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2020-10-22
Brief Title:
Impact of Computer-aided Optical Diagnosis CAD in Predicting Histology of Diminutive Rectosigmoid Polyps a Multicenter Prospective Trial ABC Study
Sponsor:
Valduce Hospital
Organization:
Valduce Hospital
Study Overview
Official Title:
Impact of Computer-aided Optical Diagnosis CAD in Predicting Histology of Diminutive Rectosigmoid Polyps a Multicenter Prospective Trial Artificial Intelligence BLI Characterization - ABC Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABC
Brief Summary:
Recently a CNN-based artificial intelligence AI system for polyp characterization has been developed by Fujifilm Co Tokyo Japan It works in conjunction with BLI system In the present study we prospectively evaluate whether the evaluation of the endoscopist combined with the CAD system output achieve 90 accuracy in characterization ie as adenomas or non-adenomas of diminutive rectosigmoid polyps having histopathology as reference standard Consecutive adult outpatients undergoing elective colonoscopy in which at least one diminutive 5 mm rectosigmoid polyp is detected are included During endoscopic procedures all polyps identified by the endoscopist are documented for size location and morphology All diminutive polyps are characterized by a three sequential steps process I endoscopist prediction the endoscopist evaluates the polyp by using BLI through the BASIC classification the confidence level high vs low in histology prediction is recorded II AI prediction the AI system is switched on and the output of the automatic evaluation is recorded this outcome is rated as stable or unstable depending of the consistency over time of the outcome III combined prediction a final classification is provided by endoscopist in light of the results of the first and of the second step the confidence level is recorded All polyps are resected and retrieved in separate jars and sent for pathology assessment Only polyps characterized with high confidence will be included in the per-polyp analysis the high-confidence characterization rate will be also calculated the rate of polyps characterized with a CAD stable outcome will be calculated Operative characteristics sensitivity specificity positive and negative predictive value and accuracy in distinguishing adenomatous from non-adenomatous polyps evaluated with high confidence will be calculated for each diminutive polyp and for each diminutive rectosigmoid polyp having histopathology report as reference standard The post-polypectomy surveillance intervals will be calculated on the basis of polyp histology reference standard in all patients according to both USMSTF and ESGE guidelines
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None