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

NCT05611151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2024-09-19

No results posted yet for this study

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)

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Meditrial USA Inc.

    collaborator INDUSTRY

  • NEC Corporation

    lead INDUSTRY

Principal Investigators

  • Hitoshi Ikeda · NEC Corporation

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2024-09-10
Completion
2024-09-10
FDA Device
Yes

Countries

  • United States
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611151 on ClinicalTrials.gov