Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT05611151
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
Sponsor:
NEC Corporation
Organization:
Study Overview
Official Title:
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation
Status:
COMPLETED
Status Verified Date:
2024-09
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:
COLOWISE
Brief Summary:
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).
Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :
* Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)
* Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :
* Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)
* Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
Detailed Description:
This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light \[HDWL\] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions.
This study plans to enrol 830 subjects aged ≥ 45 years and \< 75 years, who are scheduled for screening or surveillance colonoscopy.
After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).
All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.
This study plans to enrol 830 subjects aged ≥ 45 years and \< 75 years, who are scheduled for screening or surveillance colonoscopy.
After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).
All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: