Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

830 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2024-09-10

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Colorectal Cancer Adenoma Colon Polyp of Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel trial design

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CADe Colonoscopy

CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy

Group Type EXPERIMENTAL

Computer Aided Detection (CADe)

Intervention Type DIAGNOSTIC_TEST

Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.

HDWL Colonoscopy

HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe

Group Type ACTIVE_COMPARATOR

Computer Aided Detection (CADe)

Intervention Type DIAGNOSTIC_TEST

Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.

Interventions

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Computer Aided Detection (CADe)

Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
* Signed Informed Consent

Exclusion Criteria

1. Contraindications to colonoscopy
2. Colonoscopy within the previous three (3) years
3. High-risk indications for colonoscopy
4. Antithrombotic therapy that cannot be stopped, precluding polyp resection
5. Inflammatory bowel disease
6. Referred for endoscopic mucosal resection (EMR)
7. Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome
8. Pregnant or planning a pregnancy during the study period

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No